The FDA approved Tris Pharma’s Onyda XR to treat ADHD in children who are at least 6 years old.
It’s the first liquid non-stimulant ADHD drug approved in the US, the company announced Wednesday, and should be available beginning in the latter half of 2024.
The medication is a reformulated version of clonidine hydrochloride and is administered orally in liquid form. It’s meant to be taken once per day, including at bedtime, and can be taken alone or alongside stimulant medications.
Ketan MehtaTris CEO Ketan Mehta said in an interview with Endpoints News that Onyda XR is an alpha agonist, a class of medications that stimulates the alpha-adrenergic receptors. He said the medicine is an alternative to stimulants, which can pose challenges for some patients, like having to take it in the morning.
He said the company is still assessing how Onyda XR will be priced, but it will be in line with other ADHD medications.
“That’s where this first and only non-stimulant liquid comes into play, because until now there has not been an option like this, especially one you can take at night,” he said.
The US is still facing widespread shortages of common ADHD medications like Adderall and Vyvanse.
Common adverse reactions in people taking only Onyda XR include somnolence, fatigue, irritability, nightmare, insomnia, constipation and dry mouth.