10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor being evaluated for the treatment of attention deficit hyperactivity disorder in children, adolescents and adults.

The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with attention deficit hyperactivity disorder (ADHD) for up to one year. In total, approximately 2,500 people with ADHD were evaluated in these studies, and dasotraline was generally well tolerated.

Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development to evaluate its use in treating attention deficit hyperactivity disorder and binge eating disorder (BED). It has not been approved by the U.S. FDA for the treatment of ADHD or BED.

Read Sunovion Pharmaceuticals press release