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Study Evaluated Vyvanse® (lisdexamfetamine dimesylate) Capsules CII Efficacy and Safety in Adolescents with ADHD
Date:5/25/2010

nges in the participants' scores on the clinician administered ADHD Rating Scale IV (ADHD-RS-IV) from baseline to end point, the study's primary end point.  The ADHD-RS-IV, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association.

Least squares (LS) mean (standard error) change from baseline at end point in ADHD-RS-IV total scores (primary efficacy result) were -18.3 (1.25), -21.1 (1.28), -20.7 (1.25) for 30, 50, and 70 mg/d LDX, respectively; -12.8 (1.25) for placebo (P less than or equal to .0056 vs placebo for each) with negative differences in LS mean values indicating improvement in ADHD symptoms.

The safety of Vyvanse also was evaluated during the study.  The most frequently occurring treatment-emergent adverse events (greater than or equal to 5 percent) in all of the groups treated with Vyvanse were decreased appetite, headache, insomnia, weight decrease and irritability.  Safety results were generally consistent with the known safety profile associated with Vyvanse treatment.

Shire Development Inc. supported this study.  Dr Ann Childress is a consultant and speaker for and has received grant/research support from Shire.

Embargoed until:  Tuesday, May 25; 1:30 PM CT

About Vyvanse

Vyvanse, which was introduced in the United States in '/>"/>

SOURCE Shire plc
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