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FDA Approves Quillivant XR (Methylphenidate) for ADHD

Drug expected to be available in January 2013 (Oct. 1)

NextWave Pharmaceuticals, based in Cupertino, Calif., announced on October 1 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 with this disorder.

The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 45 children with ADHD. During an open-label dose-optimization period (4 to 6 weeks), the subjects received an initial 20-mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10- or 20-mg increments until an optimal dose or a maximum dose of 60 mg per day was reached. The subjects then received the individually optimized dose of Quillivant XR or placebo during a 2-week double-blind, crossover treatment phase.

At the end of each week, observers evaluated the attention and behavior of the subjects in a laboratory classroom using the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale. Quillivant XR significantly improved ADHD symptoms compared with placebo at the primary endpoint of 4 hours post-dose. In a secondary analysis, the drug showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

ADHD is one of the most common neurobehavioral disorders in the U.S. According to a 2009 report from the Centers for Disease Control and Prevention (CDC), almost one in ten children (9.5%) aged 4 to 17 years in the U.S. have received a diagnosis of ADHD. The condition often lasts into adulthood, with adult ADHD affecting an estimated 4% of Americans. ADHD is characterized by symptoms that include difficulty paying attention,impulsive behaviors, and in some cases hyperactivity.

Quillivant XR is expected to be available in pharmacies in January 2013.

For more information, visit the NextWave Pharmaceuticals Web site.

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