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FDA Approves Onyda XR

FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD

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.

Source: Tris Pharma News and Media

Posted: May 2024

Onyda XR (clonidine hydrochloride) FDA Approval History

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