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Vyvanse provided significant improvements in ADHD symptoms

Vyvanse provided significant improvement in attention up to 13 hours postdose1

Mean Change in SKAMP-A* (secondary endpoint)-Attention Score From Predose Measurement1

Vyvanse Graph: Mean Change in SKAMP*-Attention Score From Predose Measurement

n=113
*SKAMP-A = Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale
†P<.0001 vs placebo

Study 311: Phase 3b, randomized, double-blind, placebo-controlled, crossover, analog classroom study to assess the efficacy and safety of Vyvanse in 129 children aged 6 to 12 years with ADHD

SKAMP-Attention measurements include:

  • Starting and completing assignments
  • Sticking with tasks
  • Following directions

  • The primary objective was to assess the time of onset of Vyvanse vs placebo, as measured by the SKAMP-D scale (1.5 hours: SKAMP-D score of .70 for Vyvanse vs 1.14 for placebo; P<.0001)
  • Vyvanse treatment was associated with significant improvement in behavior, as measured by the SKAMP-D scale. The change from baseline to the first time point measured (1.5 hours) for Vyvanse was -.18 vs .43 for placebo (P<.0001). The change from baseline to the last time point measured (13 hours) for Vyvanse was .18 vs .60 for placebo (P=.001)
  • The most common adverse events (≥10% and twice placebo) reported in this study for patients taking Vyvanse during the dose-optimization phase were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability
Vyvanse demonstrated a significant improvement in behavior1

Vyvanse demonstrated significant improvement in math problems answered correctly up to 12 hours postdose1

PERMP*—Math Problems Answered Correctly† (secondary endpoint)1
Change From Predose Measurement

Vyvanse Graph: PERMP*ýMath Problems Answered Correctly. Change From Predose Measurement
  • Study was not designed as a comparative trial between active treatments

*Permanent Product Measure of Performance
†First time point postdose measured at 1 hour
‡P<.001 vs placebo
§The least squares mean change in number of math problems answered correctly at 12 hours from the first time point measured
Average of all doses tested

Study 201: Phase 2, randomized, double-blind, placebo- and active-controlled, crossover study of 52 children with ADHD aged 6 to 12 years, with MAS XR (mixed amphetamine salts extended-release) included as a reference arm. Fifty subjects received all 3 treatments—Vyvanse, MAS XR, and placebo.

Vyvanse demonstrated significant efficacy up to 12 hours postdose2
  • PERMP provides a measure of the child’s ability to pay attention and stay on task
  • Vyvanse demonstrated a significant difference in math problems answered correctly based upon the average of investigator ratings on the PERMP scale across 8 sessions of a 12-hour treatment day compared with placebo2
  • Adverse events reported in this study for patients taking Vyvanse or MAS XR that were ≥2% during the double-blind treatment period were insomnia, decreased appetite, vomiting, upper abdominal pain, and anorexia

References

  1. Data on file; LDX038; Shire US Inc.
  2. Biederman J, Boeliner SW, Childress A, et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007;62:970-976.
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