Sunovion Pharma is calling it quits on dasotraline, a dopamine and norepinephrine reuptake inhibitor it was developing for binge eating disorder and attention deficit hyperactivity disorder (ADHD). It withdrew New Drug Applications for both indications and stopped development of the program.
Sunovion, a subsidiary of Japanese pharma Sumitomo Dainippon, first filed dasotraline for approval in August 2017, for the treatment of ADHD in children, adolescents and adults. The filing was based on data from more than 2,500 people with ADHD, but the FDA decided that wasn’t enough. One year later, the agency rejected the application, saying it needed additional data to assess the efficacy and tolerability of the drug.
The company followed up with a filing in moderate to severe binge eating disorder. The FDA accepted that application last July, with a target action date of May 14, 2020. But it looks like the end of the road for dasotraline as Sunovion is halting its development and prioritizing other pipeline prospects.
The company didn’t mention specific reasons as to why it’s dumping dasotraline in binge eating disorder in addition to ADHD, saying only that it needed to do more studies to get an approval in either disorder.
“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,” the company said in a statement.
Sunovion’s pipeline has 10 central nervous system programs, ranging from phase 1 to phase 3. Its most advanced treatments target schizophrenia and off episodes in Parkinson’s disease, namely, periods of time when motor symptoms reappear.