– ONYDA XR is the first-and-only liquid non-stimulant ADHD medication available in the United States – 

– Once-a-day, nighttime dosing and extended-release profile fulfill critical unmet needs in pediatric ADHD patients six years and older –

MONMOUTH JUNCTION, NJ, October 1, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the commercial availability of ONYDA XR (clonidine hydrochloride) extended-release oral suspension. The U.S. Food and Drug Administration (FDA) approved the once-a-day liquid medication with nighttime dosing in May 2024 for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

ONYDA XR is now available through national pharmaceutical wholesalers and patients can fill prescriptions for ONYDA XR through their local pharmacies across the United States.

“Non-stimulant ADHD therapies are an increasingly important option for patients who do not respond adequately to stimulant medications or experience negative side effects from them,” said Manesh Naidu, chief commercial officer at Tris Pharma. “As ADHD Awareness Month kicks off, we’re especially pleased that ONYDA XR is now available to patients in the United States who might benefit from it as the first-and-only liquid non-stimulant ADHD medication. We look forward to expanding access to this treatment and making a meaningful difference in the lives of those living with ADHD.”

ONYDA XR was developed using Tris Pharma’s proprietary drug-delivery technology to enable a once-a-day extended-release profile, and with its liquid formulation, patients now have an option that allows for easier administration in a range of doses. ONYDA XR is the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.

“As the prevalence of ADHD continues to grow, so does the need for the availability of a wider variety of treatment options that meet the unique and individual needs of patients,” said Rakesh Jain, MD, MPH, clinical professor, Texas Tech University School of Medicine – Permian Basin. “Until now, there has not been an extended-release oral suspension non-stimulant option available to people with ADHD who may struggle taking pills or require a longer-acting therapy. The availability of ONYDA XR represents a meaningful advancement in tailoring treatment to the diverse needs of people with ADHD, and I am excited to now have this important additional medicine available for my patients.”

The U.S. FDA approval of ONYDA XR was based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets. Physicians can learn more at www.onydahcp.com.

ONYDA XR is available by prescription to pediatric patients six years and older. More information, including financial support options, is available at www.onyda.com.

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain,  addiction and disorders  of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

ONYDA (Clonidine hydrochloride)

INDICATION & IMPORTANT SAFETY INFORMATION

 INDICATION

ONYDA XR is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications:

• ONYDA is contraindicated in patients with history of a hypersensitivity reaction to clonidine.

 Warnings & Precautions:

• Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
• Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.
• Cardiac Conduction Abnormalities: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.

 Adverse Reactions:

• Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.
• Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.

 Drug Interactions:

• CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.
• Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.
• Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
• Antihypertensive drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.

 Use in specific population:

• Use in patients with renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.
• Use during pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.
  To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/.
• Use during lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see ONYDA PI for full prescribing information

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Mr. Naidu has an established track record of success with more than two decades of commercial, marketing and business development experience at leading pharmaceutical and biotechnology companies – 

MONMOUTH JUNCTION, NJ, September 17, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the promotion of Manesh Naidu, MBA, to chief commercial officer. Mr. Naidu previously served as the Company’s vice president of marketing.

“Manesh is a respected leader and experienced commercial executive with a proven track record of effectively managing and expanding brand portfolios to accelerate growth and improve access for patients to important medications,” said Ketan Mehta, founder and CEO at Tris Pharma. “In his time at Tris Pharma, Manesh has consistently demonstrated remarkable leadership in inspiring and unifying teams to deliver excellence and high performance as we collectively advance our mission to improve patient lives.”

In his new role, Mr. Naidu will lead the commercial strategy behind Tris Pharma’s ADHD portfolio to further strengthen its growth and success. His responsibilities will include leading marketing efforts for the Company’s approved medications, business development, sales strategy, market access and pricing, and product lifecycle management.

Before joining Tris Pharma in 2023, Mr. Naidu was the chief marketing officer at Althera Pharmaceutical where he led all marketing functions for the company. Mr. Naidu started his career at McKinsey & Co. and has previously held various commercial leadership positions at Mallinckrodt (formerly Ikaria Inc.), Novartis, Pfizer and Bellerophon Therapeutics where he worked in a range of functions across several therapeutic areas. Mr. Naidu received his Bachelor of Engineering in Chemical Engineering and Master of Science in Chemistry from the Birla Institute of Technology and Science in Pilani, India, a Master of Science in Chemical Engineering from Oklahoma State University and a Master of Business Administration from the Kellogg School of Management at Northwestern University.

“I feel privileged to take on the role of chief commercial officer at a pivotal time for Tris Pharma when we’re growing our portfolio of leading ADHD medications and generating new data highlighting the value of our products and unique delivery technology,” said Mr. Naidu. “As we continue our impressive track-record of delivering innovative solutions, I remain focused on expanding patient access to our therapies, broadening our product offerings and strengthening our partnerships. Together with our talented and passionate team, I’m committed to ensuring that our work ultimately has a meaningful impact on the patients, caregivers and healthcare providers we serve.” 

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Results showed that cebranopadol produces significantly less respiratory depression and other adverse respiratory effects compared to oxycodone – 

– Cebranopadol is currently being evaluated in two registrational Phase 3 studies for the treatment of moderate-to-severe acute pain –

MONMOUTH JUNCTION, NJ, September 3, 2024 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced that data from a clinical study of cebranopadol suggest the investigational pain therapy produces potent and prolonged analgesia with 25% less respiratory depression than oxycodone. Cebranopadol is the company’s first-in-class dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist designed to treat multiple types of pain. The findings will be shared in a poster presentation on September 4, 2024, at the 2024 PAINWeek conference in Las Vegas.

“We’re pleased to share these important clinical findings at PAINWeek, which highlight the respiratory safety data of cebranopadol,” said James Hackworth, Ph.D., president, brand division at Tris Pharma. “We’ve seen the detrimental impact that opioids can have on patients who suffer from pain, and we’ve worked closely with regulatory agencies to conduct multiple studies that explore specific properties of cebranopadol’s efficacy and safety profile. Based on results from these studies, we have now advanced cebranopadol into two pivotal Phase 3 studies and look forward to sharing data from these studies once they are available.”

Findings shared in the PAINWeek 2024 presentation titled “The Effects of Cebranopadol on Ventilatory Drive, Central Nervous System, and Pain,” demonstrate that NOP receptor activation with cebranopadol effectively attenuates respiratory depression and that its dual-NMR agonism produces potent, long-lasting analgesia. Key study results include:

• At equianalgesic doses, cebranopadol produces 25% less respiratory depression compared to oxycodone.
• Treatment with cebranopadol presents a significantly longer time to impact on respiratory parameters compared to oxycodone, allowing for the gradual accumulation of arterial CO2 and mitigating the full manifestation of respiratory depression.
• Cebranopadol achieved prolonged analgesic effects with gradual onset and offset.
• Despite having a longer duration of effect, cebranopadol produces fewer respiratory adverse events over 24 hours, including apnea, respiratory depression and oxygen saturation decrease, compared to oxycodone.

Respiratory depression, which is mediated by activation of the MOP receptor, is a life-threatening complication that can occur following opioid administration. In the double-blind, placebo-controlled study that will be presented at PAINWeek, investigators randomized 30 healthy volunteers over a four-week treatment period to receive cebranopadol or oxycodone at supratherapeutic doses (i.e., doses that are greater than the therapeutic concentration) or placebo. The trial specifically evaluated both cebranopadol’s and oxycodone’s impact on respiratory depression using a ventilatory response to hypercapnia model, the ability to produce analgesia and the potential presence of a respiratory depression ceiling effect for cebranopadol at higher doses.

“Respiratory depression is one of the most life-threatening and dangerous side effects of opioid use and can lead to slow, shallow and irregular breathing or even death,” said lead study author Simone Jansen, M.D., Leiden University Medical Center, Leiden, The Netherlands. “These cebranopadol data are encouraging, because they support its overall safety profile, suggesting that cebranopadol’s novel mechanism of action uniquely delays the onset of respiratory effects and produces less respiratory depression compared to oxycodone. This delayed onset has multiple advantages, including extending the timeframe for any medical interventions, if needed, and thereby could potentially help physicians feel more confident in prescribing the medication if it is approved.” 

About Cebranopadol (TRN-228)
Cebranopadol is an investigational, first-in-class dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a unique mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse or addiction while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. Studied in over 30 clinical trials in over two thousand patients, cebranopadol’s profile has been well-characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain, and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less potential for misuse or risk of physical dependence, addiction or overdose. 

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

#  #  #

Company Contact

Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact

Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Cebranopadol is a new investigational therapy that has demonstrated the potential to alter the treatment paradigm as the first dual-NMR agonist targeting both NOP and MOP receptors for a variety of pain types – 

– Cebranopadol is a potential transformative therapy to regulate pain biology in a more balanced manner; potentially as effective as opioids to treat moderate-to-severe pain while having significantly less risk of abuse, physical dependence, addiction or overdose –

MONMOUTH JUNCTION, NJ, August 21, 2024 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced today the initiation of ALLEVIATE-1 and ALLEVIATE-2, pivotal Phase 3 trials evaluating the efficacy and safety of cebranopadol for the treatment of moderate-to-severe acute pain. Cebranopadol is a first-in-class investigational new therapy, with a novel mechanism of action that targets both the nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor, called dual-NMR agonist for the treatment of multiple types of pain.

“There is a monumental need to improve upon available treatments for the millions of individuals who suffer from pain each day and are unable to live a normal life,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “The initiation of our pivotal Phase 3 clinical trials for cebranopadol, a potentially transformational new pain therapy, is a significant step toward providing patients with a solution that is both highly effective and has a strong safety profile. We look forward to sharing the results from each study when they are available.”

The ALLEVIATE-1 and ALLEVIATE-2 clinical trials are registrational Phase 3 studies evaluating the efficacy of cebranopadol in patients undergoing abdominoplasty and bunionectomy, respectively. Together, the studies will enroll more than 500 patients at clinical trial sites in the United States. The results of these registrational studies will be part of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of cebranopadol.

“Currently, physicians are constrained to prescribing pain medicines that either don’t effectively alleviate pain or do treat pain but often come with risk of significant side effects, misuse, addiction and overdose,” said Jeffrey Gudin, MD, professor of anesthesiology, perioperative medicine and pain management at the University of Miami Miller School of Medicine. “I’ve witnessed firsthand the transformative potential of this novel pain management therapy, and the initiation of these Phase 3 trials is an important step toward helping both physicians and their patients feel more confident in safely managing pain.”

If approved, cebranopadol will be the world’s first dual-NMR agonist. The investigational therapy is designed to leverage the body’s pain modulation processes, synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor to potentially deliver pain relief equivalent to opioids with minimized risk of significant side effects, dependence and potential addiction.

Cebranopadol’s profile has been well-characterized in more than 30 efficacy and safety clinical trials involving over 2,000 patients to date. Data from these studies suggest that cebranopadol is effective at reducing acute and chronic pain, including neuropathic pain, while reducing many of the harmful side effects seen in opioids and may have significantly lower risk of addiction and overdose.

About ALLEVIATE-1
The ALLEVIATE-1 clinical trial (NCT06545097) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study. Investigators at up to six clinical trial sites in the United States plan to enroll up to 300 patients. The primary objective of ALLEVIATE-1 is to evaluate the analgesic efficacy of cebranopadol compared with placebo for the management of moderate-to-severe pain following full abdominoplasty as measured by pain intensity (11-point numeric rating scale) assessments. Secondary objectives include assessing the analgesic efficacy of cebranopadol through use of rescue medication, early discontinuations and subject overall assessment of study medication.

About ALLEVIATE-2
The ALLEVIATE-2 clinical trial (NCT06423703) is a Phase 3 multicenter, randomized, double-blind, placebo- and active-controlled study. Investigators at up to eight clinical trial sites in the United States plan to enroll up to 240 patients. The primary objective of ALLEVIATE-2 is to evaluate the analgesic efficacy of cebranopadol compared with placebo for the management of moderate-to-severe pain following bunionectomy as measured by pain intensity (11-point numeric rating scale) assessments. Secondary objectives include assessing the analgesic efficacy of cebranopadol using rescue medication and evaluating the relative safety and tolerability of cebranopadol compared with oxycodone.

About Cebranopadol (TRN-228)
Cebranopadol is a first-in-class investigational therapy that targets both the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors, called a dual-NMR agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a unique mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse or addiction while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. Studied in over 30 clinical trials in over two thousand patients, cebranopadol’s profile has been well-characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain, and diabetic neuropathic pain with a significantly favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less potential for misuse or risk of physical dependence, addiction or overdose.

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products with a promising pipeline of differentiated near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Results shared at International Association for the Study of Pain (IASP) 2024 World Congress on Pain demonstrate that cebranopadol produces potent and prolonged pain relief with 25% less respiratory depression and significantly slower onset of effect with fewer respiratory adverse effects compared to oxycodone –

– Findings highlight therapeutic potential of cebranopadol, an investigational treatment with a promising, new mechanism of action designed to fill treatment gaps as a novel alternative to opioids for moderate-to-severe pain –

MONMOUTH JUNCTION, NJ, August 6, 2024 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced new clinical data demonstrating that cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist, produces significantly less respiratory depression than oxycodone. The findings will be highlighted in a poster session on August 7, 2024, at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam.

“The study findings that will be shared at IASP 2024 offer clinically meaningful evidence that cebranopadol can provide effective and equal pain management with reduced potential of respiratory depression as compared to oxycodone,” said James Hackworth, Ph.D., president, brand division at Tris Pharma. “As a first-in-class, dual-NMR agonist in development to treat moderate-to-severe pain, cebranopadol has the potential to significantly reduce side effects associated with MOP-related agonism while simultaneously lessening MOP-related abuse potential and dependence. These new respiratory data add to the growing body of evidence that supports cebranopadol’s potential as a safer alternative to opioids, and we plan to initiate Phase 3 studies very soon.”

Mediated by activation of the MOP receptor, respiratory depression is a life-threatening complication that can occur following opioid administration. The clinical study being presented at IASP compared cebranopadol to oxycodone at supratherapeutic doses (i.e., doses that are greater than the therapeutic concentration). The trial specifically evaluated both cebranopadol’s and oxycodone’s impact on respiratory depression, ability to produce analgesia, the potential presence of a ceiling effect for cebranopadol at higher doses, and the evaluation of significant respiratory depression using a model for testing ventilatory response to hypercapnia. In the double-blind, placebo-controlled study, investigators randomized 30 healthy volunteers over a four-week treatment period to receive cebranopadol, oxycodone or placebo.

Summary of Key Findings Presented at IASP 2024
Findings shared in the IASP 2024 poster presentation titled “Cebranopadol effects on ventilatory drive, central nervous system, and pain,” demonstrate that NOP receptor activation with cebranopadol effectively attenuates respiratory depression and that its dual-NMR agonism produces potent, long-lasting analgesia. Key study results include:

• At equianalgesic doses, cebranopadol produces 25% less respiratory depression compared to oxycodone.
• Treatment with cebranopadol presents a longer time to impact on respiratory parameters compared to oxycodone, allowing for the gradual accumulation of arterial CO2 and mitigating the full manifestation of respiratory depression.
• Cebranopadol achieved prolonged analgesic effects with gradual onset and offset.
• Despite having a longer duration of effect, cebranopadol produces fewer respiratory adverse events over 24 hours, including apnea, respiratory depression and oxygen saturation decrease, compared to oxycodone.

“The delayed onset of respiratory effects as evidenced in this study highlights the differentiating characteristic of cebranopadol to significantly reduce MOP-related side effects frequently experienced with opioids,” said study author Albert Dahan, M.D., professor of anesthesiology, Leiden University Medical Center, Leiden, The Netherlands. “These results reinforce the safety profile of cebranopadol by demonstrating that it gives the body time to adjust its breathing, which in turn may aid in delivering both a safe and effective pain management solution to patients. Combined with data from previous clinical and preclinical studies of cebranopadol, these findings also suggest a ceiling of respiratory depression may exist in humans and bring us closer to offering a better therapeutic for acute and chronic pain.”

About Cebranopadol (TRN-228)
Cebranopadol is an investigational, first-in-class dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a compelling and unique mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management studies, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less potential for misuse or risk of physical dependence, addiction or overdose.

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Presentation will highlight new safety data on cebranopadol, first-in-class compound with a novel mechanism of action to treat pain – 

– Tris Pharma to host symposium on dual-NMR agonists, a promising new mechanism of action in treating pain, featuring leading industry researchers –

MONMOUTH JUNCTION, NJ, July 30, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced that the company will present data from its first-in-class, late-stage investigational pain therapy with a novel mechanism of action, cebranopadol, at the upcoming International Association for the Study of Pain (IASP) 2024 World Congress on Pain, taking place August 5-9, 2024, in Amsterdam.

“I am inspired to see the rise in interest, funding and research into the development of novel treatment options for the millions of people who suffer daily from debilitating pain that impacts their quality of life,” said Ketan Mehta, founder and CEO at Tris Pharma. “Our team has been working with urgency to advance cebranopadol, a first-in-class investigational pain therapy with a novel mechanism of action, through clinical studies with the goal of offering physicians an effective treatment option that they can confidently prescribe and patients feel is safe. We look forward to collaborating with the pain community at IASP 2024 and sharing our latest findings.”

Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist in development to treat moderate-to-severe pain. Dual-NMR agonist compounds have the potential to deliver gold-standard pain relief with a strong safety profile because they mimic the body’s natural pain-modulation processes by synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor. Tris Pharma plans to share important news regarding its Phase 3 clinical trials in the near future.

Symposium Highlighting Novel Pain Mechanism
Tris Pharma will host a symposium featuring a series of presentations focused on dual-NMR agonists, a promising new mechanism of action in treating pain, and its potential to overcome the shortfalls of opioids for moderate-to-severe pain. The symposium will be presented as part of the congress by leading scientists with extensive experience in the research and development of novel pain therapies.

Details of the symposium are as follows:

Symposium: Break the Mold in Pain Biology: The Promise of a New Mechanism that May Overcome the Shortfalls of Current Moderate to Severe Pain Medications

Presenters: Charles E. Argoff, MD, Albany Medical College; Roberto Ciccocioppo, PhD, University of Camerino; Jeffrey Gudin, MD, University of Miami Miller School of Medicine

Location: RAI Amsterdam Convention Centre, Elicium I

Date and Time: August 6, 12:45 – 1:45 p.m. CEST

At IASP 2024 Tris Pharma will be present at Booth #316 where company executives will be available to provide additional information and data presented at the congress.

About Cebranopadol (TRN-228)
Cebranopadol is the first and only investigational dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a first of its kind and novel mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. The FDA has granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management studies, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less risk for misuse or risk of physical dependence, addiction or overdose. 

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– Cranbury, a new subsidiary of Tris Pharma, will market more than 20 generic medicines and advance a diverse pipeline transitioned from Tris –

– Deflazacort oral suspension is indicated to treat patients five years of age and older for Duchenne muscular dystrophy, a rare disease with limited treatment options available –

– Immediate commercial availability of therapy underscores Cranbury’s commitment to providing patients with access to effective generic medicines across multiple disease states –

MONMOUTH JUNCTION, NJ, June 12, 2024 – Business Wire – Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza^® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States.

Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease primarily affects boys, with symptom onset in early childhood. DMD occurs in approximately 1 in 5,000 live male births, and it is estimated that about 20,000 children are diagnosed with DMD globally each year.¹

“Tris Pharma founded Cranbury as part of the company’s continued commitment to develop high-quality medicines and make them accessible to individuals who need them,” said Janet Penner, president at Cranbury Pharmaceuticals. “The launch of deflazacort oral suspension aligns with this commitment, and we are proud to provide this critical therapy to those with DMD. As a tenured member of the Tris team, I am honored to take on the role of president of our new subsidiary and have the opportunity to provide important generic medicines to patients with a range of disorders and diseases.”

Tris founded Cranbury Pharmaceuticals with the vision to create high-quality, patient-friendly generic medicines that leverage Tris’ strengths in product selection, development and commercial launch. Cranbury will market more than 20 generic medicines and advance a diverse pipeline with the potential to address a range of disorders and diseases. The company will operate out of Tris’ headquarters in Monmouth Junction, New Jersey.

“Duchenne muscular dystrophy is a devastating rare disease, and with limited treatment options available there is a critical need for the greater accessibility that a generic therapy can bring,” said Ketan Mehta, founder and CEO at Tris Pharma. “This FDA approval is a significant milestone for the patients, caregivers and physicians who may depend on this medication to treat DMD. Our portfolio of differentiated, high-quality generic medications has always been core to our business at Tris, and I look forward to continuing to expand our generic offerings under our new subsidiary, Cranbury Pharmaceuticals.”

The spinout of Cranbury Pharmaceuticals follows Tris Pharma’s recent launch of Tris Digital Health, a business focused on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions. The creation of these subsidiaries within Tris facilitates important progress and enables significant continued growth for the company’s digital health and generics portfolios. Tris Pharma will continue to focus on building its commercial portfolio of approved, best-in-class ADHD products and advancing its late-stage pipeline of innovative therapeutics in pain, ADHD, neurological disorders and addiction.

INDICATION
DEFLAZACORT oral suspension is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications:

• DEFLAZACORT is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients in deflazacort oral suspension.

Warnings & Precautions:

• Alterations in Endocrine Function: Corticosteroids, such as DEFLAZACORT, oral suspension, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving DEFLAZACORT oral suspension for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after deflazacort oral suspension withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency, or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events. Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of medical stress, corticosteroid dosage may need to be increased.
• Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.
• Alterations in Cardiovascular/Renal Function: Corticosteroids, including DEFLAZACORT oral suspension, can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. DEFLAZACORT oral suspension should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be needed.
• Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, and non-specific ulcerative colitis. Signs and symptoms may be masked. Avoid corticosteroids if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.
• Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including DEFLAZACORT oral suspension. Psychiatric adverse reactions usually involve hypomanic or manic symptoms (e.g., euphoria, insomnia, mood swings) during treatment and depressive episodes after discontinuation of treatment. Encourage patients to seek medical attention if symptoms develop or worsen. especially if depressed mood or suicidal ideation is suspected.
• Effects on Bones: Corticosteroids, including DEFLAZACORT oral suspension, decrease bone formation and increase bone resorption. The risk of osteoporosis increases with prolonged use of DEFLAZACORT, which can predispose patients to vertebral and long bone fractures. Consider a patient’s risk of osteoporosis before initiating corticosteroid therapy. Monitor bone mineral density in patients on long-term treatment with DEFLAZACORT, oral suspension.
• Ophthalmic Effects: May cause cataracts, infections, and glaucoma; Monitor intraocular pressure if DEFLAZACORT oral suspension is continued for more than 6 weeks.
• Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live attenuated or live vaccines at least 4 to 6 weeks prior to starting DEFLAZACORT oral suspension.
• Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort with symptoms beginning within 8 weeks of starting treatment. Discontinue at the first sign of rash, unless the rash is clearly not drug related.
• Effects on Growth and Development: Long-term use of corticosteroids, including DEFLAZACORT oral suspension, can have negative effects on growth and development in children.
• Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use DEFLAZACORT oral suspension with caution in patients who have or may be predisposed to thromboembolic disorders.
• Adverse Reactions: The most common adverse reactions (≥10% for DEFLAZACORT Oral suspension and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.
• Drug Interactions: Give one third of the recommended dosage of DEFLAZACORT oral suspension. Avoid use of moderate or strong CYP3A4 inducers with deflazacort oral suspension, as they may reduce efficacy.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see Full Prescribing Information here.

About Cranbury Pharmaceuticals
Cranbury Pharmaceuticals is a subsidiary of Tris Pharma focused on the development and commercialization of high-quality, patient-friendly products that leverage the company’s strengths in product selection, development and commercial launch. Driven by patient-focused innovation, Cranbury will market more than 20 generic products and advance a diverse pipeline ready to transform new ideas into approved, effective medicines. Learn more at www.cranburypharma.com.

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is leveraging its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

– ONYDA XR is indicated for the treatment of ADHD as monotherapy or as adjunctive therapy to approved CNS stimulant medications in pediatric patients six years and older –

– First non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies and reinforces company’s commitment to individuals with ADHD –

MONMOUTH JUNCTION, NJ, May 29, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the U.S. Food and Drug Administration (FDA) has approved ONYDA XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

ONYDA XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing. Non-stimulant ADHD therapies are an important option for patients who do not respond adequately to stimulant medication or experience negative side effects from them, and they are increasingly used as an effective alternative to stimulant treatments. ONYDA XR is expected to be available in pharmacies in the second half of 2024.

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” said Ann Childress, M.D.  “The approval of ONYDA XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control.”

Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop ONYDA XR, a liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy. This product adds to Tris’ comprehensive and expanding portfolio of leading ADHD therapies that enhance patient care for individuals with the disorder. The company’s ADHD therapies are available in both oral suspension (liquid) and solid (tablet) forms for administration to children and adults. Tris continues to grow its ADHD offerings with a pipeline of new medications that could have a substantial impact for those with the disorder.

“Securing FDA approval for ONYDA XR is not just an important milestone, but a testament to our unwavering commitment to innovating and improving outcomes for this patient population,” said Ketan Mehta, Founder and CEO at Tris Pharma. “Our relentless pursuit to offer a range of ADHD medicines to patients of all ages does not stop here, and we look forward to continuing to expand our portfolio in other ADHD indications.”

The U.S. FDA approval of ONYDA XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain,  addiction and disorders  of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

ONYDA (Clonidine hydrochloride)

PROFESSIONAL INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION
ONYDA XR is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications:

• ONYDA is contraindicated in patients with history of a hypersensitivity reaction to clonidine.

 

Warnings & Precautions:

• Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
• Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.
• Cardiac Conduction Abnormalities: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.

 

Adverse Reactions:

• Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.
• Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.

 

Drug Interactions:

• CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.

• Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.
• Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
• Antihypertensive drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.

 

Use in specific population:

• Use in patients with renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.

• Use during pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.

To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/.

• Use during lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

 

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see ONYDA PI for full prescribing information

Company Contact

Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact

Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

–Tris Digital Health enters into licensing agreement with Braingaze to develop and commercialize first-in-class, AI-enhanced technology that offers healthcare professionals an objective tool to improve accuracy of ADHD diagnosis–

–Tris will conduct U.S. clinical trials to validate Braingaze technology ahead of commercialization in the U.S. and Canada–

MONMOUTH JUNCTION, NJ, April 16, 2024 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, has entered into a licensing agreement with Braingaze Ltd. (Braingaze) and launched its new business, Tris Digital Health, which will focus on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions.

Tris has secured exclusive rights to develop and commercialize Braingaze’s digital ADHD diagnostic platform in the United States and Canada. Braingaze is a digital health company developing technology-driven diagnostic and treatment solutions for cognitive disorders.

There has been an unmet need in ADHD for more objective tools that can help healthcare providers diagnose this disorder. The launch of Tris Digital Health and licensing of Braingaze’s digital ADHD diagnostic platform underscore Tris’ commitment to deliver innovative health products that address pressing needs in neurological health through innovative new technologies.

“Patients, caregivers and physicians deserve better tools to support accurate ADHD diagnosis beyond the currently available options,” said Ketan Mehta, founder and CEO at Tris Pharma. “We have launched Tris Digital Health to deliver on our long-term commitment to advance meaningful and beneficial healthcare for physicians, ADHD patients and caregivers. We are delighted to partner with Braingaze to launch this important endeavor and look forward to offering practitioners in the United States and Canada the opportunity to use and evaluate the benefits of this digital ADHD diagnostic platform.”

Braingaze’s first-in-class, digital biomarker-based ADHD diagnostic tool has been developed in Europe and carries the European CE Mark as a medical device. With input from the U.S. Food and Drug Administration (FDA), Tris Pharma will initiate clinical trials in the United States to further validate Braingaze’s technology as an objective ADHD diagnostic tool for clinical use in the United States and Canada.

“We’ve received enthusiastic feedback from European physicians who tell us that our novel diagnostic test is an improvement over subjective tools they relied on until now,” said Laszlo Bax, CEO and co-founder of Braingaze. “We are thrilled to partner with Tris, another leader in the ADHD space who has an exceptional track record with four commercialized medications, to extend the reach of our ADHD diagnostic solutions to patients who might benefit from it in the United States and Canada.”

Braingaze’s AI-enhanced, digital biomarker-based technology is designed to support ADHD diagnosis in children and adults. It comprises a test involving a computerized game and patented eye-tracking technology to measure individuals’ attention. Based on these measures, the test provides physicians with ADHD probability and severity scores for individual patients.

“Tris analyzed multiple investigational ADHD digital diagnostic technologies and concluded that the Braingaze test substantially outperforms other tools designed to provide objective ADHD assessment and diagnosis,” said James Hackworth, Brand Division president at Tris Pharma. “We look forward to validating this technology in U.S. patients, with the goal of providing patients, their caregivers and healthcare providers greater confidence in ADHD diagnoses to support improved outcomes.”

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

About Tris Digital Health

Tris Digital Health is a subsidiary of Tris Pharma focused on the development and commercialization of digital diagnostic and therapeutic products for mental health disorders. Tris Digital Health is focused on and committed to developing and commercializing easy-to-use digital products and services in the field of ADHD and other mental health conditions for the benefit of healthcare providers, payers, patients and their caregivers.

About Braingaze Ltd.

Started in 2013, Braingaze utilizes patented proprietary technologies to innovate digital early detection and treatment in cognitive health. The company offers a patented, scientifically, and clinically validated biomarker-based decision support system for early and objective diagnosis of ADHD and is developing early detection solutions for Autism Spectrum Disorder and cognitive diseases such as Alzheimer’s disease. In addition, it is developing gamified digital treatment that has scientifically shown to substantially improve patients’ cognitive health. Braingaze is working with leading clinics and hospitals in Europe and the United Kingdom on improving cognitive healthcare with its digital diagnostic and therapeutic tools. More information is available at www.braingaze.com and on LinkedIn @Braingaze.

For Tris:
Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com

For Braingaze:
Company Contact
Laszlo Bax
+34 931 69 65 72
press@braingaze.com

–Michael brings more than two decades of experience at global pharmaceutical, biotechnology and medical device companies–

MONMOUTH JUNCTION, NJ, February 7, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the appointment of Michael Magee as vice president, quality and compliance.

“Michael joins Tris Pharma at an incredibly exciting time in which we have an established portfolio of ADHD medications and a diverse pipeline of late-stage assets, and where his proven track record in the pharmaceutical industry will play a key role in further enhancing our ongoing quality assurance and compliance initiatives,” said Ketan Mehta, founder and CEO at Tris Pharma. “With Michael on board, we are well-positioned to navigate our growth and continue delivering on our mission to optimize patient outcomes through differentiated therapeutic approaches.”

Mr. Magee will lead and further strengthen Tris Pharma’s continued development and management of quality and compliance operations via the current Good Manufacturing Practices (cGMP) Compliance function of the organization. His responsibilities will include ensuring adherence to, and compliance with, established company quality policies, practices, and standard operating procedures and federal regulations, directing the quality of materials purchased, processed, manufactured and/or distributed by the company, and overseeing and ensuring compliance with all appropriate regulatory agencies.

“I am excited to join the Tris Pharma team and partner across the organization to drive transformational growth in key areas of the business and optimize outcomes for the patients that we serve,” said Mr. Magee. “My passion for motivating teams to have a strong, organization-wide common purpose and sense of community aligns closely with Tris Pharma’s values. Along with the company’s transformative technology and differentiated products, as well as its drug development, manufacturing and commercial capabilities that Tris Pharma is expanding to reach patients globally, the opportunity to join the company was tremendous.”

Mr. Magee brings more than 25 years of experience to Tris Pharma, most recently serving as senior vice president of quality assurance at SCA Pharmaceuticals where he led the multi-site, quality assurance division for the industry leading 503B outsourcing company. Prior to SCA, Mr. Magee held varying roles of increasing responsibility at Ferring Pharmaceuticals, Windtree Therapeutics and Johnson & Johnson, supporting quality assurance, regulatory compliance, operations, technical services and more across the companies. Mr. Magee received his Bachelor of Science in Chemistry from Moravian University and a Bachelor of Science in Pharmacy from St. Joseph’s University (Philadelphia College of Pharmacy).

“Michael brings a wealth of knowledge and a deep understanding of the regulatory and quality landscape, which will be instrumental in maintaining our unwavering commitment to developing therapeutics of the highest quality across ADHD, pain, addiction and neurological disorders,” said Nicholas Cappuccino, Ph.D., chief quality officer, senior vice president of quality & compliance at Tris Pharma. “I look forward to collaborating with Michael to further elevate our quality assurance and regulatory compliance practices.”

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Company Contact

Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact

Laura Morgan
Sam Brown, Inc.
951.333.9110
lauramorgan@sambrown.com