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FDA accepts Tris Pharma’s NDA for Dyanavel XR to treat ADHD

The US Food and Drug Administration (FDA) has accepted for review Tris Pharma's new drug application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension, for the treatment of attention deficit hyperactivity disorder (ADHD).

The agency has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October this year.

Dyanavel XR was developed using the company’s LiquiXR technology , which has been used to produced several products.

The NDA was based on a multicenter Phase III efficacy trial carried out in more than 100 patients, which showed a positive outcome by meeting all its primary end points.

Center for Psychiatry and Behavioral Medicine president and an investigator in the Dyanavel XR Phase III trial Ann Childress said: "Even though amphetamines are profoundly effective in treating ADHD, current formulations are less than ideal for pediatric patients who have difficulty swallowing pills.

"Capsule formulations may be sprinkled or dissolved but patients may not ingest all of the product or worse, may chew the sprinkles causing dose dumping.

"As an ER liquid amphetamine formulation, with a great duration of action, Dyanavel XR has the potential to fulfill an important unmet patient need."