BRIEF—Sunovion's dasotraline NDA progresses

The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults by US drugmaker Sunovion Pharmaceuticals.

The NDA submission, which was filed with the agency in September, 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 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.

“While there are a number of approved treatments for people living with ADHD, there remains a significant need for novel therapies that can address the needs of patients,” said Antony Loebel, executive vice president and chief medical officer at Sunovion, and head of global clinical development at parent company Japan’s Sumitomo Dainippon Pharma Group.