Shire to Study ADHD Drug in Preschool-Age Children

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The FDA has asked drug maker Shire to conduct pediatric clinical studies to investigate the potential use of  lisdexamfetamine dimesylate (Vyvanse) to treat attention deficit hyperactivity disorder (ADHD) in kids aged 4 to 5 years -- an age group notoriously understudied in pharmaceutical clinical trials.

Shire is in the midst of designing the three clinical trials of lisdexamfetamine dimesylate. The three studies include a pharmacokinetic study to help determine appropriate dosing, and evaluate safety and tolerability; an efficacy and safety study; and an open-label study to evaluate long-term safety. The first trial is slated to start in the first half of 2015.

FDA Asks Shire to Conduct Trials of Vyvanse in Preschool-Age Children
FDA Asks Shire to Conduct Trials of Vyvanse in Preschool-Age Children
Shire has agreed to a written request by the FDA to conduct pediatric clinical studies to investigate the potential use of lisdexamfetamine dimesylate to treat ADHD in preschool-age children, aged four to five years.
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