FDA refuses to approve Sunovion ADHD drug dasotraline

FDA decision on Sunovion ADHD drug approval : The US Food and Drug Administration (FDA) has refused to approve Sunovion Pharmaceuticals’ dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) dasotraline for the treatment of attention-deficit hyperactivity disorder (ADHD).

The regulator said that it cannot approve the New Drug Application (NDA) for the ADHD drug in its present form while indicating that more clinical data is required to further assess the efficacy and tolerability of dasotraline for ADHD treatment.

Commenting on the FDA decision on Sunovion ADHD drug approval, Antony Loebel – Executive Vice President and Chief Medical Officer at Sunovion, said: “While we are disappointed with the FDA’s decision, we remain confident in the future of dasotraline.

“We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible.”

Sunovion ADHD drug dasotraline fails to win FDA approval
Sunovion ADHD drug dasotraline fails to win FDA approval. Photo courtesy of David Castillo Dominici at FreeDigitalPhotos.net.

The Sunovion ADHD drug was tested in nearly 2,500 children and adults with ADHD in multiple placebo-controlled safety and efficacy trials and also in two long-term safety trials.

Dasotraline is also being evaluated for the treatment of moderate to severe binge eating disorder (BED) in adults in the US.

Sunovion believes that the positive data from two pivotal trials will back an expected marketing application submission to the FDA for dasotraline for the treatment of the binge eating disorder during FY2018.