FDA Approves Non-Stimulant ADHD Medication

The FDA has approved Tris Pharma’s Onyda XR (clonidine hydrochloride) to treat patients 6 years of age and older with attention deficient hyperactivity disorder (ADHD).

Onyda XR is a once-a-day extended-release oral suspension with and can be used as a monotherapy or as an adjunctive therapy to stimulant ADHD medications. It is expected to be in pharmacies in the second half of 2024.

Tris’s founder and CEO, Ketan Mehta said the company is in the process of determining pricing and they expect to release pricing details closer to launch. Additionally, the company is in the process of determining coverage details and company executives anticipate having final details available closer to the time of launch.

“In making our medicines available to patients, we place incredibly high priority on patient access and are conscious of broader market dynamics in play,” he told Formulary Watch.

Onyda was developed using Tris’ LiquiXR technology, which allows for extended release for both tablet and liquid formulations.

Clonidine is an antihypertensive but has been used to treat patients with ADHD because of its ability to affect the brain that controls attention and impulsivity. And because of its sedative effects, clonidine may help patients experiencing insomnia.

Two clinical studies evaluated 256 patients in two eight-week placebo-controlled studies. A third study evaluated 135 pediatric patients 6 to 17 years of age in a 40-week placebo-controlled randomized-withdrawal study, according to the label.

Study one was a short-term study of patients 6 to 17 years old. Common adverse events included somnolence, fatigue, irritability, insomnia, nightmare, constipation and dry mouth. Study two studied a flexible dose of extended release clonidine as adjunctive to a stimulant. The most common side effects in study two were somnolence, fatigue, decreased appetite and dizziness.

Although experience with clonidine has shown the medication is not to associated with major birth defects, a pregnancy exposure registry monitors outcomes for pregnant women exposed to ADHD medications.

Tris markets several products to treat patients with ADHD, including the amphetamine extended release product Dyanavel XR in both a tablet and liquid formulations and the methylphenidate extended release products QuilliChew ER, a tablet, and Quillivant XR, a liquid.

Additionally, in April, Tris entered into a licensing agreement with Braingaze and launched a new business, Tris Digital Health. The new business will focus on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions. Tris will develop and commercialize Braingaze’s ADHD diagnostic platform in the United States and Canada.

Braingaze is a digital health company developing diagnostic and treatment solutions for cognitive disorders. The company offers a portfolio of games designed to improve attention skills in children with ADHD, autism and dyslexia.