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FDA approves Vyvanse® (lisdexamfetamine dimesylate) for adolescent ADHD

November 15, 2010
by News release
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Philadelphia - Shire plc (LSE: SHP, Nasdaq: SHPGY) today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) capsules 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 by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). The ADHD-RS-IV rating scale is a measure of the core symptoms of ADHD. The core symptoms of ADHD are inattention, hyperactivity and impulsivity. All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.

The safety of Vyvanse was also evaluated during the study. The most frequently occurring treatment-emergent adverse events (greater than or equal to 5 percent and twice placebo) reported in patients treated with Vyvanse were decreased appetite, insomnia, and weight decrease. Safety results were generally consistent with previous Vyvanse studies in children and adults. Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Vyvanse is a stimulant medication. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

Additional information about Vyvanse and Full Prescribing Information and Medication Guide, including WARNING about Potential for Abuse, are available at http://www.vyvanse.com.

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