Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
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.
