Complete Response Letter for dasotraline to treat ADHD.- Sunovion Pharma.

Sunovion Pharmaceuticals Inc. announced that the 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.