Tris wins FDA approval for first liquid non-stimulant ADHD med
30 May 2024
Drug ApprovalAcquisition
Tris Pharma received FDA approval of Onyda XR (clonidine hydrochloride), a once-daily extended-release oral suspension for treating ADHD in children aged six and older.
This medication is the first and only liquid non-stimulant ADHD treatment in the United States also featuring nighttime dosing. Approved for use either alone or alongside stimulant medications, the drug offers an alternative for patients who do not respond well to stimulants or experience negative side effects.
Tris Pharma used its proprietary LiquiXR technology to develop the drug, aiming for an extended-release profile that provided consistent therapeutic effects throughout the night. The approval was based on studies demonstrating the safety and efficacy of clonidine hydrochloride in extended-release form.
Tris, known for manufacturing medications with unique delivery systems, has been strengthening its ADHD pipeline for a few years. In 2018, the company acquired NextWave Pharmaceuticals, a subsidiary of Pfizer. The acquisition included two key ADHD treatments, Quillivant XR and QuilliChew ER.
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