Sunovion announced that it has decided to withdraw the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, for the treatment of moderate to severe binge eating disorder (BED) and attention deficit hyperactivity disorder (ADHD).
The NDA for dasotraline was first filed in August 2017 for the treatment of ADHD based on data from over 2500 children and adults. In August 2018, the Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) stating the application required additional data to further assess the efficacy and tolerability of dasotraline.
After the Agency issued the CRL, the Company submitted the application for the binge eating disorder indication, which was accepted for review in July 2019 with a Prescription Drug User Fee Act (PDUFA) date of May 14, 2020.
In a press statement, the Company noted that “while Sunovion considers dasotraline to be a promising, novel treatment for BED and ADHD, we believe that further clinical studies would be needed to support a regulatory approval for dasotraline in these indications.” As such, the Company will not pursue further development of the drug at this time.
For more information visit sunovion.com.