Industry Briefs

ADHD Treatment Dyanavel XR Receives Nod from FDA

On October 20, Tris Pharma Inc. announced that the Food and Drug Administration has approved Dyanavel XR (amphetamine) extended-release oral suspension for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6 years and older. The medication is the first once-daily, extended-release, amphetamine-based oral liquid approved for the treatment of ADHD in children.

The approval was based on a phase 3 study of 108 children (aged 6 to12) with ADHD. Children who took Dyanavel XR demonstrated improvements in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined score at four hours post dosing. Dyanavel XR also met key secondary endpoints by demonstrating an onset of clinical effect at one hour that persisted through 13 hours post dosing compared with placebo. Most common adverse effects included nose bleeds, allergic rhinitis, and upper abdominal pain.