The FDA approved ONYDA XR, a once-daily extended-release oral suspension with nighttime dosing, for the treatment of attention deficit hyperactivity disorder in pediatric patients aged ≥ 6 years. The medication, developed by Tris Pharma, Inc., can be used as a monotherapy or as an adjunctive therapy to approved central nervous system stimulant medications.
ONYDA XR (clonidine hydrochloride) is the first-and-only liquid non-stimulant attention deficit hyperactivity disorder (ADHD) medication approved in the U.S. The approval was based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets. The medication is expected to be available in pharmacies in the second half of 2024.
The full prescribing information for ONYDA XR, including dosage, administration, warnings, precautions, and clinical trial data, is available in the FDA-approved label.