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Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
Date:11/12/2009

PHILADELPHIA, Nov. 12 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years. The post hoc analysis showed that patients demonstrated an improvement in emotional lability composite CPRS-RS scores while taking Vyvanse as compared to placebo. These results were presented recently at a psychiatric meeting in Honolulu.

"Children taking ADHD medications can experience emotional lability, often described as frequent changes in emotions or mood. Therefore, evaluating the impact of ADHD treatments, including Vyvanse, on children's emotional lability may be important for parents and health care professionals when assessing a child's treatment plan," said Ann C. Childress, MD, study investigator and president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas.

About the Analysis and Study

This post hoc analysis was based on a Phase 3, randomized, double-blind, placebo-controlled trial with forced-dose escalation of Vyvanse (30, 50, or 70 mg/d) or placebo in 285 children aged 6 to 12 years with ADHD. The primary end point of the study was the ADHD-RS IV, and secondary end points included CPRS-RS and safety. The CPRS-RS scale in its entirety contains 27 items to evaluate children's behaviors based on parents' responses. Each of the CPRS-RS 27 items is scored from zero
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SOURCE Shire plc
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