FDA approves Dyanavel XR (amphetamine extended release oral) for Attention-deficit/hyperactivity disorder- Tris Pharma

The FDA has approved Dyanavel XR (amphetamine extended release oral), from Tris Pharma, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6 years and older. With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children.

FDA approval is based on a Phase III randomised, placebo-controlled, laboratory classroom efficacy study conducted in 108 children (ages 6 to 12 years, who met DSM-IV criteria for ADHD). The study, which included a 5-week, open-label dose optimisation followed by a 1-week, double-blind treatment period, demonstrated a positive outcome by meeting its primary endpoint of change from pre-dose in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) combined score at 4 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. The most common adverse reactions (at least 2% in the Dyanavel XR group and greater than placebo) reported in the study were: epistaxis (nose bleed), allergic rhinitis and upper abdominal pain.