NextWave Pharmaceuticals announced that the FDA hasapproved Quillivant XR (methylphenidate hydrochloride extended-release oralsuspension) for the treatment of attention deficit hyperactivity disorder(ADHD). Quillivant XR is the first once-daily extended-release liquidmethylphenidate available for patients.

The approval for Quillivant XR was based on a randomized,double-blind, placebo-controlled, crossover, multicenter study of 45 childrenwith 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 dosewas 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 theindividually optimized dose of Quillivant XR or placebo. Results showed thatQuillivant XR significantly improved ADHD symptoms compared to placebo at theprimary endpoint of four hours post-dose. A secondary analysis showedsignificant improvement at every time point measured, from 45 minutes to 12hours after dosing.

Quillivant XR is expected to become available in January2013 in a 25mg/5mL strength suspension. 

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