Shire announced that the labeling for Vyvanse (lisdexamfetamine dimesylate) has been updated to include data regarding the approval of a supplemental New Drug Application (sNDA). 

The labeling now includes maintenance of efficacy data from the Phase 3 SPD489-346 study, the first longer-term pharmacologic study (38 weeks) in adults aged 18–55 years with moderate to severe binge eating disorder. The study results show that patients treated with Vyvanse (n=136) had significant maintenance of efficacy vs. the placebo group (n=131) based on the primary endpoint of time to relapse (P<0.001). 

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For the double-blind, placebo-controlled, randomized-withdrawal phase of the study (26 weeks), relapse was defined as having ≥2 binge days per week for 2 consecutive weeks prior to any visit, as well as an increase in the Clinical Global Impressions-Severity (CGI-S) score of ≥2 points relative to the randomized-withdrawal baseline visit. By the end of the study, maintenance of efficacy with Vyvanse was established in patients who had an initial response to treatment during the open-label phase, and then continued treatment during the randomized-withdrawal phase; Vyvanse proved to be superior to placebo as measured by time to relapse. 

Vyvanse, a central nervous system (CNS) stimulant, is a CII substance indicated for adults with moderate to severe binge eating disorder and attention deficit hyperactivity disorder (ADHD). It is available as 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg strength capsules in 100-count bottles.

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