Tris Pharma receives USFDA approval for ONYDA XR, a liquid non-stimulant ADHD medication

Tris Pharma, a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the USFDA 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 paediatric 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 US 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. The company’s ADHD therapies are available in both oral suspension (liquid) and solid (tablet) forms for administration to children and adults. 

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. 

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