November 15, 2010
Vyvanse gains indication for ADHD in adolescentsThe FDA has approved Vyvanse (lisdexamfetamine dimesylate capsules, from Shire) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13–17 years of age. This approval was based on data from a randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study of 314 adolescents 13–17 years of age who received one of three Vyvanse doses, 30mg/day, 50mg/day and 70mg/day, or a placebo. All Vyvanse dose groups were superior to placebo in the primary efficacy outcome, which was the change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS).
Vyvanse, a C-II controlled drug, is already indicated for treating ADHD in children 6–12 years old and adults.
For more information call (800) 828-2088 or visit www.vyvanse.com.