SPD489-346 was 39-week, multi-center, placebo-controlled, double-blind, dose-optimized, randomized-withdrawal study. The study evaluated the maintenance efficacy between Vyvanse and placebo based on the primary endpoint of time to relapse of binge eating symptoms in adults with moderate-to-severe BED. The study consisted of a four-week screening period, a 12-week open-label treatment phase, followed by a 26-week double-blind, randomized-withdrawal phase, and a follow-up visit one week after the last on-treatment visit.
During the 26-week 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%).
Shire plans to submit a supplemental New Drug Application (sNDA) to the FDA for Vyvanse for moderate-to-severe BED by the end of the year. The submission will be based on these results as well as data from a separate 12-month open-label safety extension study. The FDA will evaluate adding these data to the current labeling for Vyvanse.
Vyvanse is already indicated for the treatment of moderate-to-severe BED in adults and attention deficit hyperactivity disorder (ADHD) in ages ≥6.
For more information call (800) 536-7878 or visit Shire.com.