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FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
Date:5/4/2010

eling is based on a 14-hour modified analog classroom study of Vyvanse to simulate a workplace environment in 142 adults who met DSM-IV-TR criteria for ADHD.  The data support the results of a previous Phase 3 clinical study of adults with ADHD in which Vyvanse significantly improved the ADHD symptoms of inattention (for example, lack of focus), as well as of hyperactivity and impulsivity, as measured by the ADHD Rating Scale (ADHD-RS-IV) with adult prompts, a standard validated tool.  The most common treatment-emergent adverse events in patients taking Vyvanse in this previous study were decreased appetite, trouble sleeping, dry mouth, nausea, diarrhea, anxiety and loss of appetite.

As with other stimulant medications, Vyvanse is classified as a controlled substance (CII) because of its potential for abuse.

About the Study

The data that led to this approval of revised labeling for Vyvanse was from a multi-center, randomized, double-blind, placebo-controlled, crossover study in 142 adults who met DSM-IV-TR criteria for ADHD.  Following a 4-week, open-label, dose-optimization phase with Vyvanse (30, 50, or 70 mg/day in the morning), subjects were randomized to one of two treatment sequences:  Vyvanse (optimized dose) followed by placebo, each for one week, or placebo followed by Vyvanse, each for one week.  Efficacy assessments occurred at the end of each week, using the PERMP.  The PERMP is a skill-adjusted math test that measures attention in ADHD.  Vyvanse treatment, compared to placebo, resulted in a statistically significant improvement in attention across all postdose time poin
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