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US FDA Approves Lisdexamfetamine Dimesylate for the Treatment of ADHD in Adolescents

November 15, 2010

On November 12th, the United States Food and Drug Administration approved lisdexamfetamine dimesylate (Vyvanse, Shire) for the treatment of ADHD in adolescents between 13–17 years of age. Lisdexamfetamine dimesylate has previously been approved for the treatment of ADHD in children 6–12 years of age and adults >18 years of age. Adolescent patients should be initiated on lisdexamfetamine dimesylate 30 mg/day, which can be titrated 20 mg/week, up to a maximum of 70 mg/day.

Approval was based on a randomized, double-blind, placebo-controlled study of 314 adolescents between 13–17 years of age meeting DSM-IV criteria for ADHD. The patients were randomized to receive lisdexamfetamine dimesylate 30 mg/day, 50 mg/day, 70 mg/day, or placebo. At endpoint, all three lisdexamfetamine dimesylate dosage groups were found to have improvements in inattention, hyperactivity, and impulsivity symptoms compared to placebo.

The most commonly observed adverse events, which affected >5% of patients studied, included decreased appetite, insomnia, and weight decrease.

For additional safety and prescribing information, please visit — Christopher Naccari


From → FDA Report

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