Shire presents two studies of Vyvanse for long term maintenance of efficacy in binge-eating disorder

Shire plc reported positive top-line results from a 39-week, long-term maintenance of efficacy study of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) in adults with moderate to severe binge-eating disorder (BED) (Study SPD489-346).The objective of the study was to evaluate the maintenance of efficacy between Vyvanse and placebo, based on the primary endpoint of time to relapse of binge-eating symptoms in adults (aged 18 to 55) with moderate to severe BED. During the 26-week, double-blind, randomized-withdrawal phase of the study, 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 (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, Shire plans to submit a supplemental New Drug Application to the FDA by year end. The FDA will evaluate adding these data to the current labelling for Vyvanse.

In a separate 12-month open-label safety extension study (SPD 489-345) in adults with moderate to severe BED, the safety profile for Vyvanse was generally consistent with that currently outlined in the Prescribing Information. During the 52-week open-label treatment phase, 17 patients treated with Vyvanse experienced serious adverse events (SAEs) and 54 patients on Vyvanse had treatment-emergent adverse events (TEAEs) that led to study discontinuation. The most commonly reported TEAEs in patients taking Vyvanse (reported in 5% or more of patients) included dry mouth, headache, insomnia, upper respiratory tract infection, nasopharyngitis, constipation, nausea, decreased appetite, irritability, bruxism, sinusitis, anxiety and feeling jittery.

Comment: In 2013, the American Psychiatric Association (APA) recognized BED, the most common eating disorder in US adults, as a distinct medical condition. The disorder occurs in both men and women, is seen across racial and ethnic groups, and can occur in normal weight, overweight and obese adults. Medication is not appropriate for all adults with BED.

Comment: Vyvanse (also marketed as Elvanse) has not yet been approved in the EU for this condition.