Binge Eating Disorder

January 30, 2017

Sunovion Pharmaceuticals reported results of a phase II/III study (SEP360-221), the first of two planned pivotal studies, evaluating its novel drug candidate dasotraline in adults ages 18 to 55 years with moderate to severe binge eating disorder (BED). SEP360-221 was a 12-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled, flexible-dose study administered once-daily in doses ranging from 4 to 8mg or placebo. The primary efficacy endpoint was the change from baseline in number of binge days (defined as days during which at least one binge episode occurs) per week at week 12. Top-line data show that dasotraline was statistically superior to placebo on the primary efficacy endpoint and all key secondary efficacy endpoints: CGI-S, Y-BOCS-BE and percent of subjects with a four-week cessation from binge eating. Adverse events were consistent with completed adult dasotraline studies and include insomnia, dry mouth, decreased appetite, anxiety, nausea and decreased weight.

August 3, 2015

Shire issued results of a phase III study of a 39-week, long-term maintenance of efficacy study of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) in adults with moderate to severe binge-eating disorder (B.E.D.). The study consisted of a four-week screening period, a 12-week open-label treatment phase (four weeks of dose optimization and eight weeks of maintenance), and a 26- week, double-blind, randomized-withdrawal phase, as well as a follow-up visit one week after the last on-treatment visit. During the dose-optimization period, all Vyvanse-treated patients were initiated at the 30mg dose, and then titrated in 20mg increments to their optimal dose (either 50mg or 70mg). Patients who met response criteria—one or fewer binge days each week for four consecutive weeks prior to the last visit at the end of the 12-week open-label phase, and had a Clinical Global Impression-Severity (CGI-S) score of two or less at the same visit—were randomized to Vyvanse or placebo treatment groups. During this randomized-withdrawal phase, patients (N=275) received either ongoing treatment with the same optimized dose of Vyvanse from the open-label phase (N=137) or placebo (N=138). Vyvanse demonstrated superiority over placebo (p<0.001) on the primary efficacy endpoint of time to relapse. Additionally, at the conclusion of the study, the group continuing on Vyvanse had a significantly lower proportion of relapse of (5/136, 3.7%) as compared to the placebo group (42/131, 32.1%). Based on these results, as well as findings from a separate 12-month open-label safety extension study, the company plans to submit a supplemental NDA to the FDA by year-end. The FDA will evaluate adding these data to the current labeling for Vyvanse.

August 20, 2012

Lightlake Therapeutics reported results from a phase II trial of intranasal naloxone for the treatment of Binge Eating Disorder (BED). This randomized, double-blind, placebo-controlled, six-month study enrolled 127 patients in Helsinki, Finland. Subjects receiving the naloxone nasal spray achieved the study’s primary endpoint by exhibiting a statistically significant reduction in time spent per week binge eating (125 minutes/week reduction) compared to those patients who received a placebo nasal spray (84 minutes/week reduction) (p=0.024). During the last week of treatment, naloxon-treated patients reduced their bingeing by 158 minutes/week compared to 101 minutes/week for placebo-treated subjects (p=0.018). Patients with a BMI>35 (considered severely obese) had particularly impressive results: naloxon-treated patients reduced their bingeing by 210.8 minutes/week compared to 83.8 minutes/week for the placebo-treated patients during the last week of the trial (p=0.004). The nasal spray was well tolerated. Adverse events were the same in both the placebo and naloxon groups. Lightlake Therapeutics did not note its plans for intranasal naloxone, but said longer use of the nasal spray would produce even better results.

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