Clonidine Hydrochloride

Pictured: FDA's signage outside its office in Silver Spring, Maryland/iStock, hapabapa The FDA on Wednesday signed off on Tris Pharma’s reformulation of clonidine hydrochloride for the treatment of attention deficit hyperactivity disorder in pediatric patients aged six years and older. The once-daily drug will be marketed under the brand name Onyda XR. Onyda XR is the first FDA-approved non-stimulant medication for attention deficit hyperactivity disorder (ADHD) with a liquid formulation and nighttime dosing, according to Tris. The biotech aims to make Onyda XR available in U.S. pharmacies by the second half of 2024. Ketan Mehta, founder and CEO of Tris Pharma, in a statement called Wednesday’s approval an “important milestone” that can provide a new therapeutic option that improve treatment outcomes for patients. “We look forward to continuing to expand our portfolio in other ADHD indications.” Clonidine is a well-established pharmaceutical compound that first won the FDA’s approval in 1974 for the treatment of high blood pressure. According to Onyda XR’s label, it works by stimulating alpha 2-adrenergic receptors in the brain, though its exact mechanism of action in ADHD is still unknown. Clonidine is not a stimulant of the central nervous system. In ADHD, Clonidine was approved in 2010 under the brand name Kapvay, which is owned by Shionogi. Kapvay is indicated for children and adolescents aged six to 17 years of age and can be given alone or on top of stimulant medication. Onyda XR was developed using Tris’ LiquiXR platform, producing a “smooth, extended-release profile,” according to the company. Its approval was supported by well-controlled studies of the extended-release medication. With Wednesday’s approval, Onyda XR will help address a substantial and growing gap in the ADHD market, which is currently suffering from a protracted and record-breaking shortage of medicines due to continuing global supply chain problems and manufacturing quality issues. The patent expiration for Takeda’s oral amphetamine Vyvanse (lisdexamfetamine dimesylate)—a top-seller in the ADHD market, bringing in $2.52 billion between March 2021 and 2022—will also open up the space for generics that could help alleviate the shortage. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Tris Pharma received FDA approval of Onyda XR (clonidine hydrochloride), a once-daily extended-release oral suspension for treating ADHD in children aged six and older. This medication is the first and only liquid non-stimulant ADHD treatment in the United States also featuring nighttime dosing. Approved for use either alone or alongside stimulant medications, the drug offers an alternative for patients who do not respond well to stimulants or experience negative side effects. Tris Pharma used its proprietary LiquiXR technology to develop the drug, aiming for an extended-release profile that provided consistent therapeutic effects throughout the night. The approval was based on studies demonstrating the safety and efficacy of clonidine hydrochloride in extended-release form. Tris, known for manufacturing medications with unique delivery systems, has been strengthening its ADHD pipeline for a few years. In 2018 , the company acquired NextWave Pharmaceuticals, a subsidiary of Pfizer. The acquisition included two key ADHD treatments, Quillivant XR and QuilliChew ER.