Tris gets FDA nod for first liquid non-stimulant ADHD drug

Tris Pharma has announced the approval of Onyda XR (clonidine hydrochloride) by the FDA. This medication is a once-daily, extended-release oral suspension designed to treat Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older. Onyda XR stands out as the first and only liquid, non-stimulant ADHD treatment in the United States that also allows for nighttime dosing.

The medication can be utilized either as a standalone treatment or in combination with stimulant medications. This flexibility is particularly beneficial for patients who do not respond well to stimulants or who experience adverse side effects from them. By offering a non-stimulant option, Onyda XR provides an important alternative in the management of ADHD.

The development of Onyda XR leverages Tris Pharma's proprietary LiquiXR technology. This advanced formulation ensures an extended-release profile, delivering consistent therapeutic effects throughout the night. The FDA's approval was granted based on rigorous studies that confirmed the safety and efficacy of clonidine hydrochloride in its extended-release form.

Tris Pharma is recognized for its innovative approaches to medication delivery systems. The company has been enhancing its ADHD treatment portfolio over the years. Notably, in 2018, Tris Pharma acquired NextWave Pharmaceuticals, a subsidiary of Pfizer. This acquisition included two significant ADHD treatments: Quillivant XR and QuilliChew ER, further bolstering Tris Pharma's position in the ADHD treatment market.

Onyda XR's approval marks a significant milestone in ADHD treatment, particularly for patients who require a non-stimulant option. The extended-release capability and nighttime dosing feature provide a tailored approach to managing ADHD symptoms, potentially improving the quality of life for many children and their families.