"This study provides important information for physicians about the effect of treatment with VYVANSE throughout the day in adults," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "Shire is committed to providing effective treatments for adults with ADHD who need significant symptom improvement through the day and into the evening. We are proud to have evaluated VYVANSE in adults in this workplace-like environment."
The adult simulated workplace environment study supports the results of a previous phase 3 clinical trial in adults in which once-daily VYVANSE significantly improved ADHD symptoms of inattention, such as the ability to focus and organize, as well as hyperactivity and impulsivity. In this previous study, the most common adverse events (greater than or equal to 5 percent and twice placebo) were decreased appetite, dry mouth, insomnia, nausea, diarrhea, anxiety, and anorexia.
About the Adult Simulated Workplace Environment Study
This randomized, double-blind placebo-controlled, crossover study evaluated the efficacy and safety of three doses of VYVANSE, 30 mg, 50 mg, and 70 mg, compared to placebo in 142 adults with ADHD using the adult simulated workplace environment setting. A four-week, open-label phase to identify the optimal dose preceded the two-week double-blind phase in which efficacy was evaluated.
The primary efficacy measure of the study was the average of postdose PERMP total scores in adults taking VYVANSE compared to placebo. The key secondary efficacy measure was to assess the duration of efficacy of VYVANSE compared to placebo using PERMP; the PERMP total score is the sum of the number of math problems attempted (PERMP-A) plus the number of math problems answered correctly (PERMP-C) in a 10-minute session.
|Contact: Matthew Cabrey (Shire North America)|