Quillivant XR Approved for Treatment of ADHD
NextWave Pharmaceuticals announced that the FDA has approved Quillivant XR (methylphenidate hydrochloride extended-release oral suspension) for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR is the first once-daily extended-release liquid methylphenidate available for patients.
The approval for Quillivant XR was based on a randomized, double-blind, placebo-controlled, crossover, multicenter study of 45 children with ADHD. There was an open-label dose optimization period (four to six weeks) with an initial 20mg dose of Quillivant XR once daily in the morning. The dose was titrated until an optimal dose or maximum dose of 60mg per day was reached. Patients then entered a two-week double-blind, crossover treatment of the individually optimized dose of Quillivant XR or placebo. Results showed that Quillivant XR significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose. A secondary analysis showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.
Quillivant XR is expected to become available in January 2013 in a 25mg/5mL strength suspension.
For more information call 800-206-8115 or visit www.quillivantxr.com.