Phase IIIb study of Vyvanse/Elvanse (Shire) shows significant benefits for treating young patients with ADHD

A Phase IIIb study comparing the efficacy and safety of the Attention Deficit Hyperactivity Disorder (ADHD) treatments shows Vyvanse/Elvanse (lisdexamfetamine dimesylate), from Shire provides significant benefits. SPD489-317 was a 9-week, double blind, randomised, active-controlled, parallel-group study of 267 patients aged 6-17 years old with at least moderately symptomatic ADHD, and which compared Vyvanse/Elvanse with atomoxetine (ATX). Median time to first clinical response was significantly faster for patients receiving Vyvanse/Elvanse (12 days) than for ATX (21 days). The secondary efficacy outcome highlighted that, at each weekly visit, a significantly greater proportion of patients had responded to treatment with Vyvanse/Elvanse compared with ATX.

Additionally, Vyvanse/Elvanse was associated with significantly greater reductions in core ADHD symptoms than ATX treatment (based on ADHD-RS-IV total score and inattentiveness and hyperactivity/impulsivity subscale scores). Safety results were generally consistent with the known safety profiles from other previous clinical trials. Vyvanse was approved by the FDA for children with ADHD in May 2013. Results were presented at the 4th World Congress on ADHD.