Lisdexamfetamine: A Review in Binge Eating Disorder

Abstract

Oral lisdexamfetamine dimesylate (Vyvanse®; lisdexamfetamine), a prodrug of dextroamfetamine, is currently the only drug to be approved in the USA for the treatment of moderate to severe binge eating disorder (BED) in adult patients. Its approval was based on the results of two pivotal short-term (12weeks) phase III studies, which showed a significantly greater reduction in binge eating days/week at the end of the study with lisdexamfetamine 50-70mg/day than with placebo. The findings of these studies have been supported and extended by the results of longer-term (≤52weeks) phase III studies, including one with a randomized 26-week withdrawal phase, which showed that lisdexamfetamine markedly reduced the risk of BED relapse relative to placebo. Lisdexamfetamine was generally well tolerated in clinical trials in patients with moderate to severe BED, with a tolerability profile similar to that observed in ADHD patients; most treatment-emergent adverse events (TEAEs) were of mild or moderate intensity. The most common TEAEs in phase III trials included dry mouth, headache and insomnia; TEAEs infrequently led to study drug discontinuation. In conclusion, lisdexamfetamine 50-70mg/day is an effective and generally well tolerated option for treating moderate to severe BED in adults.