Shire's Vyvanse improves ADHD in adults

UK drugmaker Shire presented positive results from a Phase III pivotal study in which Vyvanse (lisdexamfetamine dimesylate) demonstrated significant improvements in attention-deficit hyperactivity disorder symptoms in adults and met all safety and efficacy endpoints.

In this double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years, treatment with Vyvanse at all doses studied (30mg, 50mg, 70mg) provided a significant reduction in ADHD Rating Scale scores within one week that were observed throughout the full treatment period. At endpoint, Vyvanse demonstrated a significant improvement in ADHD symptoms, based on a 43% reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date. Results from the study were presented at the annual meeting of the American Psychiatric Association in Washington DC.

Investigators also measured the efficacy of Vyvanse with the Clinical Global Impressions-Improvement scale and found that the percentage of subjects taking Vyvanse rated much or very much improved was approximately 60% across all doses and was significantly greater than placebo.