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FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
The U.S. Food and Drug Administration (FDA) approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older.
“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” said Ann Childress, MD, in a press release. “The approval of ONYDA XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control.”
Related: Several Treatments Effective in Youth With ADHD, but Evidence Strongest for Medication
Clonidine hydrochloride, a centrally acting alpha2-adrenergic agonist, is the only approved liquid, non-stimulant medication for ADHD and the only approved non-stimulant with nighttime dosing. Though clonidine was originally approved by the FDA in 1974 as a treatment for high blood pressure, it was only recently approved for use in ADHD in 2010. This recent approval was “based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets,” Tris Pharma, Inc. said in a press release.
Clonidine hydrochloride is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. It has listed drug interactions with central nervous system (CNS) depressants, tricyclic antidepressants, antihypertensive drugs, and drugs that are know to affect sinus node or AV nodal conduction.
Clonidine hydrochloride is slated to be available in pharmacies in the second half of 2024.
