Pharma Focus Asia

Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

Saturday, November 11, 2017

Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) 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.

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 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.”

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