FDA Approves Tris Pharma's Non-Stimulant ADHD Drug

The FDA approved Tris Pharma’s new formulation of clonidine hydrochloride for treating ADHD in children aged six and older on Wednesday. The new once-daily medication will be sold under the brand name Onyda XR. This approval marks the first time a non-stimulant liquid formulation with nighttime dosing has been sanctioned by the FDA for ADHD treatment, according to Tris Pharma. The company plans to have Onyda XR available in U.S. pharmacies by mid-2024.

Ketan Mehta, the founder and CEO of Tris Pharma, hailed the FDA’s approval as a significant achievement, providing an essential new treatment option for ADHD patients. He emphasized the company's commitment to expanding its range of ADHD therapies.

Originally approved by the FDA in 1974 for high blood pressure treatment, clonidine hydrochloride works by activating alpha 2-adrenergic receptors in the brain. Although its precise mechanism in treating ADHD remains uncertain, clonidine is known not to stimulate the central nervous system. In the context of ADHD, clonidine was approved in 2010 under the name Kapvay, which is managed by Shionogi. Kapvay is prescribed for children and adolescents aged six to 17 and can be used alone or with stimulant medications.

Onyda XR was developed using Tris Pharma’s LiquiXR platform, which provides an extended-release profile. The FDA’s approval of Onyda XR was based on rigorous, well-controlled studies demonstrating its efficacy.

The approval of Onyda XR comes at a crucial time, as the ADHD medication market is currently facing significant supply chain issues and manufacturing quality problems, leading to a substantial shortage of medicines. This shortage has been unprecedented and prolonged, creating a growing gap in the market.

Additionally, the expiration of the patent for Takeda’s Vyvanse (lisdexamfetamine dimesylate), a leading ADHD medication that generated $2.52 billion between March 2021 and 2022, will create opportunities for generic alternatives. These generics could help mitigate the ongoing medication shortage.

The new approval by the FDA for Onyda XR is poised to offer a much-needed alternative for the treatment of ADHD, especially in light of the current challenges facing the industry. This new medication provides a novel option for patients and healthcare providers, potentially improving treatment outcomes for children with ADHD.

As Tris Pharma moves forward, the company aims to continue its efforts in developing new therapies for ADHD, addressing the complex needs of patients and contributing to the broader medical landscape.