Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder - Seite 2

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 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 (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 ≥ 5% and at least twice placebo) reported in adults with moderate to severe B.E.D. were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

About B.E.D. 

Binge eating disorder, now recognized as a distinct disorder, is defined as recurring episodes (≥ once weekly, for at least 3 months) of consuming a large amount of food in a short time, compared with others.  Patients feel a lack of control during a binge eating episode and marked distress over their eating.  They typically experience shame and guilt, among other symptoms, about their binge eating, and may conceal the symptoms. Unlike people with other eating disorders, adults with B.E.D. don't routinely try to "undo" their excessive eating with extreme actions like purging or over-exercising.