Shire announced that the FDA has approved Vyvanse (lisdexamfetamine dimesylate) capsules for the maintenance treatment in children and adolescents ages >6 years with ADHD. Vyvanse, a schedule II substance stimulant, is already approved for the treatment of ADHD in adults and children and for maintenance of ADHD in adults 18–55 years old.
This approval is based on results from a 32-week study (26 weeks of open-label treatment with Vyvanse followed by a 6-week randomized withdrawal phase) to evaluate the continued efficacy of Vyvanse in patients aged 6–17 years (N=276). Study results showed that a significantly lower proportion of treatment failures occurred among Vyvanse patients (15.8%) vs. placebo (67.5%) at end point of the randomized withdrawal period.
Vyvanse capsules are available in 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg dosage strengths.
For more information call (800) 828-2088 or visit the Vyvanse website.