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.
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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From Pharmaceutical Business Review
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