October 27, 2016
SAN ANTONIO — Poster data presented here indicated efficacy and safety of Dyanavel XR, an extended-release oral suspension amphetamine for attention-deficit/hyperactivity disorder in children aged 6 years and older.
To assess efficacy and safety of Dyanavel XR (amphetamine, Tris Pharma), Ann C. Childress, MD, of the Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, and colleagues conducted a randomized, double-blind study among 108 children with ADHD. Study participants had a mean age of 9.4 years. Participants began treatment with 2.5 mg or 5 mg of extended-release amphetamine per day and were titrated in 2.5 mg to 10 mg per day increments until an optimal dose was achieved. Maximum dosage was 20 mg per day. Participants received amphetamine or placebo for 7 days. Efficacy was assessed at 1, 2, 4, 6, 8, 10, 12 and 13 hours’ post-dose.