Sunovion Pharmaceuticals submits new US drug application for dasotraline.

M2 EQUITYBITES-September 5, 2017-Sunovion Pharmaceuticals submits new US drug application for dasotraline

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It was reported yesterday that United States-based Sunovion Pharmaceuticals has submitted a new drug application to the US Food and Drug Administration for dasotraline, a novel investigational, dual-acting dopamine and norepinephrine reuptake inhibitor.

The product is for the treatment of children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).

The company has supported data from a clinical programme for dasotraline in attention deficit hyperactivity disorder, which included four placebo-controlled safety and efficacy studies, and two long-term studies that evaluated patients for up to one year. In total, around 2,500 patients with attention deficit hyperactivity disorder were assessed in these studies using dasotraline dosages in the range of two mg/day to eight mg/day. Dasotraline was found to be generally well tolerated.

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