Regulatory Affairs

Sunovion seeks FDA approval for dasotraline to treat patients with ADHD

Published 04 September 2017

Sunovion Pharmaceuticals announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline, a novel investigational, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).

Dasotraline’s pharmacokinetic properties, such as an extended half-life, and clinical study findings support its potential for sustained control of ADHD symptoms over the 24-hour dosing interval with once-daily dosing.

“This milestone embodies Sunovion’s commitment to advancing psychiatry and neurology through the development of novel treatment options to improve the lives of those living with behavioral health conditions. People with ADHD suffer from inattention, as well as hyperactive-impulsive behaviors that may interfere with school, work and social functioning,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group.

 “Dasotraline is a once-daily medication that may add to current treatment options by providing sustained symptom improvement without wearing off between doses. In addition, studies indicate that dasotraline is associated with a relatively low potential for abuse. We look forward to working closely with the FDA to bring this important new treatment option to people living with ADHD.”

The NDA submission is supported by data from the clinical program for dasotraline in ADHD, which included four placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in patients with ADHD for up to one year. In total, approximately 2,500 patients with ADHD were evaluated in these studies utilizing dasotraline dosages in the range of 2 mg/day to 8 mg/day. Dasotraline was generally well tolerated.

Dasotraline is also being investigated for the treatment of binge eating disorder (BED) in adults.

Dasotraline is a new chemical entity that acts as a dual dopamine and norepinephrine reuptake inhibitor (DNRI). It has an extended half-life (47-77 hours) that supports the potential for stable plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval.

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

Source: Company Press Release