Vyvanse (lisdexamfetamine dimesylate) is a drug commonly prescribed in the treatment of attention deficit hyperactivity disorder (ADHD). It had been previously approved for use in children ages 6 to 12 years and adults. But it was technically not approved by the U.S. Food and Drug Administration (FDA) for teens ages 13 to 17. However, I’m sure that didn’t stop doctors from prescribing it to this group of older children, given it was approved for prescription to younger children.
Well, now everyone can sleep more easily tonight — Vyvanse gained FDA approval for use in teens on Monday.
According to the article noting the drug’s new approval was based upon a single randomized, double-blind placebo-controlled 4-week study conducted on 314 teens, ages 13 to 17, who met the criteria for ADHD:
In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo [...]. All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated by 20 mg per week until they achieved their assigned dose.
The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). [...] All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.
The safety of Vyvanse was also evaluated during the study. The most frequently occurring treatment-emergent adverse events reported in patients treated with Vyvanse were: decreased appetite, insomnia, and weight decrease. Safety results were generally consistent with previous Vyvanse studies in children and adults.
Vyvanse was first offered during the summer of 2007.
Disclosure: Vyvanse advertises on Psych Central.
This is an announcement only, so there are no comments.
Last reviewed: By John M. Grohol, Psy.D. on 17 Nov 2010
Published on PsychCentral.com. All rights reserved.
Grohol, J. (2010). FDA Approves Vyvanse for Teens. Psych Central. Retrieved on October 25, 2014, from http://psychcentral.com/blog/archives/2010/11/17/fda-approves-vyvanse-for-teens/