FDA Accepts Sunovion’s New Drug Application for Treatment of ADHD for Review
Sunovion Pharmaceuticals have announced that the FDA has accepted for review their New Drug Application for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults.
The New Drug Application 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 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, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We are pleased that the FDA has accepted our New Drug Application for dasotraline and look forward to working closely with the Agency so that we can bring this important treatment option to people with ADHD.”
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 or BED.
Materials provided by Sunovion Pharmaceuticals. Note: Content may be edited for style and length.