Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD).
Upon completion of their review, the FDA determined that they cannot approve the dasotraline NDA for the treatment of ADHD in its current form. The Agency indicated that additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline for the treatment of ADHD. Sunovion plans to meet with the FDA to discuss their comments and determine next steps.
Dasotraline was evaluated in approximately 2,500 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, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible."
Dasotraline is also being studied for the treatment of moderate to severe binge eating disorder (BED) in adults in the U.S. Data from two positive pivotal studies will support an expected marketing application submission to the FDA for dasotraline to treat BED in FY2018.