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FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Date:11/15/2010

PHILADELPHIA, Nov. 15, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17.  The approval is based on study data demonstrating that Vyvanse improved ADHD symptoms compared to placebo in adolescents with ADHD. Vyvanse is also indicated for the treatment of ADHD in children ages 6 to 12 years, and adults.

"This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms," said Mike Yasick, Senior Vice President of Shire's ADHD Business.  "The approval of Vyvanse for children and adults – and now for adolescents – underscores Shire's commitment to helping ADHD patients and their families."  

The FDA's approval of Vyvanse in adolescents was based on results from a randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study of adolescents who received one of three Vyvanse doses, 30, 50 and 70 mg/day, or a placebo.  This study was conducted in 314 adolescents aged 13 to 17 who met DSM-IV-TR® criteria for ADHD.  In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo for a total of four weeks of treatment.  All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated
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