FDA approves Onyda XR extended-release liquid nonstimulant ADHD drug

Key takeaways:

• The FDA approved the treatment for patients with ADHD aged 6 years and older.
• Onyda XR is the first and only liquid nonstimulant ADHD medication in the United States.

The FDA has approved Onyda XR extended-release oral suspension for the treatment of ADHD among children aged 6 years and older, according to a press release from Tris Pharma, Inc.

Onyda XR (clonidine hydrochloride, Tris Pharma) is the first and only liquid nonstimulant ADHD medication in the United States and the only approved nonstimulant ADHD drug with nighttime dosing, according to the release. The FDA approved the drug for once-daily dosing, and it can be used as a monotherapy or with central nervous system-stimulant medications.

In clinical trials, the most common adverse reactions included somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth, decreased appetite and dizziness.

The drug will be available in pharmacies in the second half of 2024, according to Tris Pharma.

“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,” Ketan Mehta, founder and CEO of Tris Pharma, said in the release. “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.”