Dasotraline meets endpoint in adults with binge eating disorder but not ADHD

A Phase II/III study (SEP360-221), the first of two planned pivotal studies, evaluating the novel drug candidate dasotraline in adults aged 18 to 55 years with moderate to severe binge eating disorder (BED) met the primary efficacy endpoint as well as all key secondary efficacy endpoints.

The drug’s developer, Sunovion Pharmaceutical, a US subsidiary of Japanese pharma company Sumitomo Dainippon Pharma (TYO: 4506), also announced that the Phase III study (SEP360-301) evaluating dasotraline in adults aged 18 to 55 years with attention deficit hyperactivity disorder (ADHD) did not meet its primary endpoint.

“We are pleased to see such strong results in our first major study of dasotraline in patients with binge eating disorder,” said Antony Loebel, executive vice president and chief medical officer at Sunovion, and head of global clinical development for Sumitomo Dainippon Pharma Group. “We remain confident in the potential for dasotraline to offer a new, differentiated therapeutic option for adults with BED as well as children and adults with ADHD. We look forward to sharing the results of our ongoing clinical studies,” Dr Loebel added.