- In a mixed bag of results from the SEP360-321 pivotal study, Sunovion's dasotraline met its primary endpoint of statistically significant decrease in number of binge days per week compared with placebo at the higher dose of 6 mg but not the lower dose of 4 mg. The company hasn't provided any more details, other than stating that they will be analyzed and presented at a future scientific meeting.
- In the earlier SEP 360-221 pivotal Phase 2/3 flexible dose study, dasotraline at 4-8 mg per day statistically significantly improved the number of binge days per week compared with placebo, and also significantly improved a number of other binge eating measures.
- Both sets of data will form the basis of a planned supplemental New Drug Application submission to the Food and Drug Administration before the end of 2018 for use in adults with moderate-to-severe binge eating disorder.
There are few launched drugs or drugs in the pipeline for use in binge eating disorder, but it could be a market with a lot of potential, both for improved patient outcomes and for company pipelines. Shire's Vyvanse (lisdexamfetamine dimesylate) has been approved. Chronos Therapeutics has an OX1 antagonist, CT-010018, in preclinical development, and Opiant Pharmaceuticals is conducting a Phase 2 trial of a nasally-delivered opioid antagonist, OPNT001.
"While binge eating disorder is the most common eating disorder in the U.S., few approved treatment options are available," said Antony Loebel, EVP and CMO at Sunovion, in a statement. "We’re encouraged by the positive top-line results… [that] suggest that dasotraline may provide an important new treatment option for people with binge eating disorder."
The disorder is a type of mental illness where eating is out of control, and may be done without intention. As well as being associated with depression, distress, guilt and disordered thinking, it can lead to gastroesophageal reflux disease, joint problems, obesity, raised cholesterol, type 2 diabetes and heart disease. Treatment includes psychotherapy and nutritional therapy. According to the National Eating Disorders Association, binge eating disorder may affect up to 3.5% of women and 2% of men, and fewer than half of these will get treatment in their lifetime.
Dasotraline has also been submitted to the FDA for approval for attention deficit hyperactivity disorder (ADHD), with a user fee goal date of Aug. 30, 2018.