First binge eating disorder drug approved

January 31, 2015

FDA approved lisdexamfetamine dimesylate (Vyvanse, Shire) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week.

FDA approved lisdexamfetamine dimesylate (Vyvanse, Shire) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week.

Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions. Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence.

According to the National Eating Disorders Association, BED is a type of eating disorder that is characterized by recurrent binge eating without the regular use of compensatory measures to counter the binge eating. BED is the most common eating disorder in the United States and affects women (60%) slightly more often than men (40%).

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Symptoms include frequent episodes of consuming very large amount of food but without behaviors to prevent weight gain, such as self-induced vomiting; a feeling of being out of control during the binge eating episodes; feelings of strong shame or guilt regarding the binge eating; and indications that the binge eating is out of control, such as eating when not hungry, eating to the point of discomfort, or eating alone because of shame about the behavior.

Health risks of BED are most commonly those associated with clinical obesity: High blood pressure; high cholesterol levels; heart disease; diabetes mellitus; gallbladder disease; and musculoskeletal problems

Efficacy of Vyvanse in the treatment of BED was demonstrated in two 12-week randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (Study 1: N=374, Study 2: N=350) with protocol-defined moderate to severe BED (severity was defined as having at least 3 binge days per week for 2 weeks prior to the baseline visit and a Clinical Global Impression Severity score of ≥4 at baseline). The primary efficacy outcome for the 2 studies was defined as the change from baseline at week 12 in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the baseline visit.

Subjects from both studies on Vyvanse had a statistically significant greater reduction from baseline in mean number of binge days per week at Week 12. In study 1, Vyvanse reduced the mean number of binge days per week from 4.79 at baseline to 0.78 at study end point compared with 4.60 to 2.22 for placebo. The least squares mean change from baseline in binge days per week was –3.87 and –2.51 for Vyvanse and placebo, respectively. Similar results were seen in study 2.

Greater improvement across key secondary outcomes was also observed in subjects treated with Vyvanse as compared to placebo, including a higher proportion of subjects rated improved on the Clinical Global Impressions-Improvement (CGI-I) rating scale, higher proportion of subjects with 4-week binge cessation, and greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score in both studies.

Patients with current anorexia or bulimia nervosa; current comorbid psychiatric disorder; and cardiovascular risk factors other than obesity and smoking were excluded from the studies. In both studies, there were 4 patients each in the Vyvanse and placebo-treated groups who reported serious adverse events. There were no deaths in either of the studies. Of patients treated with Vyvanse, 5.1% discontinued due to adverse reactions compared with 2.4%  of placebo-treated patients.

The most common adverse reactions reported in adults with moderate to severe BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.