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. ■