FDA declines approval for Sunovion’s ADHD drug dasotraline, citing need for more data

In a regulatory setback, the U.S. Food and Drug Administration (FDA) has decided not to approve Sunovion Pharmaceuticals’ dasotraline, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD). The FDA has requested additional clinical data to further evaluate the drug’s efficacy and safety.

The FDA’s refusal to approve the New Drug Application (NDA) for dasotraline highlights concerns regarding the need for more comprehensive data to ascertain the treatment’s efficacy and tolerability for patients with ADHD. This decision comes despite dasotraline being tested in nearly 2,500 children and adults across multiple placebo-controlled safety and efficacy trials, including two long-term safety studies.

Reacting to the FDA’s decision, Antony Loebel, Executive Vice President and Chief Medical Officer at Sunovion, expressed disappointment but remained optimistic about the future of dasotraline. “While we are disappointed with the FDA’s decision, we remain confident in the future of dasotraline,” said Loebel. Sunovion plans to engage with the FDA promptly to discuss the next steps for the dasotraline ADHD program.

Beyond ADHD, dasotraline is also under evaluation for the treatment of moderate to severe binge eating disorder (BED) in adults. Sunovion anticipates that positive data from two pivotal trials will support a marketing application submission for dasotraline to treat BED during FY2018.

The FDA’s decision not to approve dasotraline for ADHD treatment underscores the challenges in drug development, particularly in addressing complex disorders like ADHD. Sunovion’s commitment to pursuing further dialogue with the FDA reflects the company’s dedication to advancing psychiatric and neurological care by addressing unmet medical needs.

The FDA’s request for additional data before approving new ADHD treatments such as dasotraline is indicative of the agency’s rigorous standards for safety and efficacy. This decision highlights the complexities of developing treatments for neurological disorders, where balancing therapeutic benefits with potential risks is paramount. Sunovion’s ongoing efforts to refine dasotraline’s clinical profile will be crucial as they move forward with regulatory discussions and potential future submissions.