Sunovion Pharmaceuticals announced last week that the Food and Drug Administration (FDA) has accepted its New Drug Application for dasotraline for the treatment of moderate to severe binge eating disorder. The FDA's action date for the novel dopamine and norepinephrine reuptake inhibitor is May 14, 2020.
Two 12-week placebo-controlled trials of dasotraline have found significant efficacy for the drug, which also has been found to be generally well-tolerated in other studies. The studies have looked at use of the drug in an overall dosage range of 4 to 8 mg per day.
“Binge eating disorder is a serious mental health condition for which limited treatment options exist,” Sunovion president and CEO Antony Loebel, MD, said in a news release. “The disorder is often seen in association with other behavioral conditions such as depression, substance abuse and post-traumatic stress disorder, and it is often underdiagnosed and undertreated.”
The Massachusetts-based drugmaker also is examining other potential indications for dasotraline, including for the treatment of attention-deficit/hyperactivity disorder (ADHD).