Two Phase IV trials report data on Vyvanse for ADHD - Shire

Shire has announced top-line results from two Phase IV efficacy and safety studies of Vyvanse (lisdexamfetamine dimesylate) compared with Concerta (methylphenidate HCl) with a placebo reference arm in adolescents aged 13-17 diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). In SPD489-406, the forced-dose titration study, Vyvanse was found to be statistically superior to Concerta on the primary efficacy analysis with mean reductions on the ADHD RS-IV total score of 25.4 and 22.1 points, respectively. In SPD489-405, the dose optimization study, neither Vyvanse nor Concerta was found to be statistically superior to the other on the primary efficacy analysis, with a larger mean improvement found for Vyvanse than Concerta (mean reductions on the ADHD-RS-IV total score of 25.6 and 23.5 points, respectively).

The primary efficacy endpoint for both studies was defined as the change from baseline in ADHD-RS-IV total score at Week 6 and Week 8, respectively. In both studies, the types of adverse events appear to be generally consistent with the known safety profile for Vyvanse established in studies of adolescents with ADHD. Shire plans to submit the efficacy and safety data from the two studies for presentation at a future scientific congress.