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VYVANSE CII provided significant efficacy at 14 hours in adults with ADHD
Date:7/1/2009

Hollywood, FL July 1, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a Phase 3b study that found VYVANSE (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these data were presented today at the 49th annual New Clinical Drug Evaluation Unit meeting in Hollywood, FL. VYVANSE is currently approved by the US Food and Drug Administration (FDA) for the treatment of ADHD in children age 6 to 12 years and in adults with ADHD.

"Long-acting medication may be important for adults with ADHD because ADHD symptoms, such as inattention, hyperactivity, and impulsivity, may impact them at work, as well as in at least one other area of their life," said Matthew Brams, MD, study author and psychiatrist in private practice with Bayou City Research, Ltd in Houston. "In this study, adults taking VYVANSE demonstrated significant efficacy as measured by the Permanent Product Measure of Performance (PERMP), from two hours, the first time point measured, up to 14 hours following administration. Additionally, adults taking VYVANSE demonstrated significant ADHD symptom improvement, as measured by the ADHD Rating Scale (ADHD-RS) with adult prompts. These findings may be important for adults who require ADHD symptom management at work, at home, and in social settings."

In this study, investigators evaluated adults with ADHD in an adult simulated workplace environment setting. In this setting, adults engaged in tests and activities that require a level of attention needed in many workplace settings. The efficacy of VYVANSE was measured by PERMP, a validated, time sensitive, skill adjusted math test designed to evaluate an adult's ability t
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Contact: Matthew Cabrey (Shire North America)
484-595-8248
Porter Novelli
Source:Eurekalert

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