The US Food and Drug Administration (FDA) has rejected the new drug application (NDA) for dasotraline (Sunovion Pharmaceuticals), a novel dual-acting dopamine and norepinephrine reuptake inhibitor, for the treatment of attention-deficit/hyperactivity disorder (ADHD).
After review, the FDA said that it could not approve the NDA for dasotraline in its current form and that additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline for the treatment of ADHD.
Dasotraline was evaluated in about 2500 children and adults with ADHD in multiple placebo-controlled safety and efficacy studies, as well as two long-term safety studies.
"While we are disappointed with the FDA's decision, we remain confident in the future of dasotraline," said Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, in a news release. "We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible."
Dasotraline is also being evaluated for the treatment of moderate to severe binge eating disorder in adults in the United States. On the basis of positive data from two studies, the company said it expects to file a marketing application for dasotraline for binge eating disorder by the end of March 2019.
Medscape Medical News © 2018
Cite this: FDA Says No to Dasotraline for ADHD - Medscape - Aug 31, 2018.