FDA Approves Tris Pharma's Liquid Non-Stimulant for Pediatric ADHD

Tris Pharma has announced that the FDA has granted approval for Ondya XR (clonidine hydrochloride) for use in pediatric patients with attention-deficit hyperactivity disorder (ADHD). This medication is a once-daily, extended-release non-stimulant oral suspension designed to be taken at night. It can be used on its own or in conjunction with stimulant medications for children as young as six years old. The company highlighted that Ondya XR is the first liquid non-stimulant ADHD treatment approved in the United States and is expected to become available in U.S. pharmacies in the latter half of the year.

Non-stimulant ADHD treatments are essential for patients who either do not respond well to stimulant medications or experience significant side effects from them. Tris Pharma's CEO, Ketan Mehta, emphasized that securing FDA approval for Ondya XR is a significant achievement and reflects the company's ongoing dedication to improving outcomes for patients with ADHD.

The approval of Ondya XR is based on data from well-controlled studies involving clonidine hydrochloride extended-release tablets. Clonidine itself has a long history of clinical use; it was first introduced in 1966 as a centrally acting anti-hypertensive medication and continues to be widely prescribed for various conditions. The extended-release tablet form of clonidine hydrochloride, marketed under the name Kapvay by Shionogi, received FDA approval in 2010 specifically for ADHD treatment.

In addition to Ondya XR, Tris Pharma’s current range of oral extended-release ADHD medications includes Dynavel XR (amphetamine) and Quillivant XR/QuilliChew ER (methylphenidate hydrochloride). These formulations have been developed using the company's proprietary LiquiXR technology, which aims to enhance the delivery and efficacy of extended-release medications. Furthermore, Tris Pharma’s development pipeline features several candidates targeting ADHD, pain, addiction, and other neurological disorders.

The introduction of Ondya XR expands the treatment options for children with ADHD, providing a non-stimulant alternative in a liquid form that may be easier for young patients to take. This approval marks a pivotal step in the ongoing effort to offer diverse and effective treatment options for managing ADHD, particularly for those who may struggle with the side effects or lack of efficacy associated with traditional stimulant medications.