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FDA accepts NDA for dasotraline for ADHD
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Sunovion Pharmaceuticals Inc. recently announced the FDA accepted for review a New Drug Application for dasotraline, a novel-acting dopamine and norepinephrine reuptake inhibitor, for treatment of ADHD in children and adults.
Dasotraline is currently in development for treatment of ADHD and binge-eating disorder. It has not been approved by the FDA for either indication.
The NDA submission is based on multiple placebo-controlled safety and efficacy studies and two long-term studies that assessed safety of dasotraline for individuals with ADHD for up to 1 year. Approximately 2,500 individuals with ADHD were assessed among these studies.
Dasotraline was generally well tolerated, according to researchers.
“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,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in a press release. “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.”