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

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.Shire Development Inc. supported this study.  

About VyvanseVyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

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

INDICATION  Vyvanse is a prescription medicine for the treatment of ADHD in children
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SOURCE Shire plc
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