{"id":2040,"date":"2023-09-25T13:30:51","date_gmt":"2023-09-25T12:30:51","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/?p=2040"},"modified":"2023-11-30T11:04:49","modified_gmt":"2023-11-30T11:04:49","slug":"tris-pharma-secures-first-ex-us-authorizations-for-quillivant-er-oral-suspension-and-quillivant-er-chewable-tablet-for-the-treatment-of-attention-deficit-hyperactivity-disorder","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-secures-first-ex-us-authorizations-for-quillivant-er-oral-suspension-and-quillivant-er-chewable-tablet-for-the-treatment-of-attention-deficit-hyperactivity-disorder\/","title":{"rendered":"Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder"},"content":{"rendered":"

[vc_row][vc_column][vc_column_text]<\/p>\n

\u2013 Potential to address unmet need for millions of Canadian children and their parents with fast-acting, long-lasting liquid and chewable tablet \u2013 <\/em><\/p>\n

MONMOUTH JUNCTION, NJ, September 25, 2023\u00a0\u2013 Business Wire \u2013 Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant\u00ae ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR\u00ae and QuilliChew ER\u00ae, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.<\/p>\n

\u201cChildren with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,\u201d said Ketan Mehta, founder and chief executive officer at Tris Pharma. \u201cWe are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.\u201d<\/p>\n

Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.<\/p>\n

ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet).<\/p>\n

In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company\u2019s proprietary LiquiXR\u00ae technology.<\/p>\n

\u201cQuillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,\u201d said John McKendry, president at KYE Pharmaceuticals. \u201cOur strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.\u201d<\/p>\n

About Tris Pharma<\/strong><\/p>\n

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\u00a0www.trispharma.com<\/a>\u00a0and on LinkedIn @TrisPharma<\/a>.<\/p>\n

About KYE Pharmaceuticals<\/strong><\/p>\n

Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team\u2019s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information, please visit\u00a0www.kyepharma.com<\/a>.<\/p>\n

Company Contact<\/strong><\/p>\n

Cheryl Patnick
\nTris Pharma, Inc.
\ncpatnick@trispharma.com<\/a><\/p>\n

Media Contact<\/strong><\/p>\n

Andrea Cohen
\nSam Brown, Inc.
\n917.209.7163
\nandreacohen@sambrown.com<\/a>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column][vc_column_text] \u2013 Potential to address unmet need for millions of Canadian children and their parents with fast-acting, long-lasting liquid and chewable tablet \u2013 MONMOUTH JUNCTION, NJ, September 25, 2023\u00a0\u2013 Business Wire \u2013 Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":"","_wp_rev_ctl_limit":""},"categories":[28],"tags":[],"class_list":["post-2040","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"featured_image_src":{"landsacpe":false,"list":false,"medium":false,"full":false},"yoast_head":"\nTris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder - Tris Pharma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.trispharma.com\/tris-pharma-secures-first-ex-us-authorizations-for-quillivant-er-oral-suspension-and-quillivant-er-chewable-tablet-for-the-treatment-of-attention-deficit-hyperactivity-disorder\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder - Tris Pharma\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_column_text] \u2013 Potential to address unmet need for millions of Canadian children and their parents with fast-acting, long-lasting liquid and chewable tablet \u2013 MONMOUTH JUNCTION, NJ, September 25, 2023\u00a0\u2013 Business Wire \u2013 Tris Pharma, Inc. 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