Industry Briefs

Sunovion Submits NDA for Investigational ADHD Drug

Sunovion Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its investigational compound dasotraline for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults.

Dasotraline is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) with a half-life of 47 to 77 hours.

The NDA submission for dasotraline is supported by data from four placebo-controlled safety and efficacy studies, as well as two long-term, open-label safety studies, which evaluated about 2,500 patients with ADHD.

Dasotraline is also being investigated for the treatment of binge-eating disorder in adults. ■