{"id":1710,"date":"2022-10-19T19:39:19","date_gmt":"2022-10-19T18:39:19","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharma-announces-continued-supply-and-availability-of-dyanavel-xr-amphetamine-tablets-and-oral-suspension-for-adhd-despite-adderall-shortage\/"},"modified":"2022-10-19T19:39:19","modified_gmt":"2022-10-19T18:39:19","slug":"tris-pharma-announces-continued-supply-and-availability-of-dyanavel-xr-amphetamine-tablets-and-oral-suspension-for-adhd-despite-adderall-shortage","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-announces-continued-supply-and-availability-of-dyanavel-xr-amphetamine-tablets-and-oral-suspension-for-adhd-despite-adderall-shortage\/","title":{"rendered":"Tris Pharma Announces Continued Supply and Availability of DYANAVEL\u00ae<\/sup> XR (amphetamine) Tablets and Oral Suspension for ADHD Despite Adderall shortage"},"content":{"rendered":"

Once daily extended release provides early onset and full day coverage<\/strong> <\/p>\n

MONMOUTH JUNCTION, NJ, October 19, 2022 PRNewswire\/ – Tris Pharma, Inc. (Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that DYANAVEL\u00ae<\/sup> XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL\u00ae<\/sup> XR (amphetamine) extended-release oral suspension, CII are stocked by wholesalers and continue to be available in pharmacies. DYANAVEL XR was approved by the U.S. Food and Drug Administration for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Dyanavel XR may be an option for health care providers and patients who can no longer fill their prescription of Adderall due to a stocking shortage.<\/p>\n

In a double-blind, placebo-controlled, fixed-dose Phase 3 study in adults with ADHD, DYANAVEL XR tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all measured post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose). The PERMP-T is a validated and FDA-accepted, skill-adjusted, timed math test that is used to assess attention in people with ADHD. The most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study. These finds were recently published in The Journal of Clinical Psychiatry (Cutler, et al. J Clin Psychiatry 2022. 83(00):22m14438).<\/p>\n

In another clinical study in healthy adults, DYANAVEL XR extended-release tablets were deemed to be bioequivalent to DYANAVEL XR (amphetamine) extended-release oral suspension CII, which in a Phase 3 clinical study of children aged 6 to 12 years with ADHD, demonstrated ADHD symptom improvement within 1 hour, that lasted through 13 hours after once-daily dosing.<\/p>\n

\u201cWith the Innovative Tris portfolio of ADHD products, we are committed to help Providers and Patients through their treatment journey. DYANAVEL XR Tablet and DYANAVEL XR oral suspension provide quality treatment options for adult and pediatric patients 6 years and older with ADHD who need an amphetamine\u201d, said Dr. James Hackworth, President of the Tris Branded Products Division.<\/p>\n

DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs.<\/strong> Keep DYANAVEL XR in a safe place to protect it from theft. Never give your DYANAVEL XR to anyone else because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law. See additional important safety information below.<\/p>\n

About Tris Pharma<\/strong>
\nTris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories. Tris\u2019s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit www.trispharma.com<\/a> and www.trismedical.com<\/a>.<\/p>\n

APPROVED USE<\/strong>
\nDYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.<\/p>\n

It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/strong>
\nDYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others and is against the law. <\/strong><\/p>\n

Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.<\/p>\n

DYANAVEL XR should not be taken if you or your child<\/strong> are allergic to amphetamine or any of the ingredients in DYANAVEL XR or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.<\/p>\n

DYANAVEL XR can cause serious side effects. Tell the doctor: <\/strong><\/p>\n