The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) 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.

"Binge eating disorder is the most common adult eating disorder in the U.S., and we are excited to provide the first FDA-approved treatment for moderate to severe BED in adults," said Philip J. Vickers, Ph.D., global head of R&D at Shire. "This new indication for Vyvanse is a critical milestone in the treatment of this condition and reflects our ongoing commitment to address the needs of patients."

"The management of BED continuously is being studied, and though advancements have been made to increase awareness and understanding of this real disorder, rates of diagnosis remain low," said Susan L. McElroy, M.D., professor of psychiatry and behavioral neuroscience, University of Cincinnati College of Medicine; and Principal Investigator of the BED

clinical trials. "The development of new treatment options for adults with BED is important to the patients who continue to live with this complex disorder."

The efficacy of Vyvanse in the treatment of BED was demonstrated in two 12-week randomized, double-blind, multi-center, 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 three binge days per week for two weeks prior to the baseline visit and a Clinical Global Impression Severity score of greater than or equal to 4 at baseline).

The primary efficacy outcome for the two 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 endpoint 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.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.

Greater improvement across key secondary outcomes also was 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 four patients each in the Vyvanse and placebo treated groups who reported serious adverse events (SAEs). There were no deaths in either of the studies. Of patients treated with Vyvanse, 5.1% (19/373) discontinued due to adverse reactions compared with 2.4% (9/372) of placebo-treated patients. The most common adverse reactions (incidence greater than or equal to 5% and at least twice placebo) reported in adults with moderate to severe BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery and anxiety.