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Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
Date:10/29/2008

as this study demonstrated symptom control during a 13-hour treatment day," said Mike Cola, President of Shire's Specialty Pharmaceuticals business. "This VYVANSE study further supports Shire's commitment to research efforts that address the need for ADHD symptom control throughout the day, and into the evening."

About the 13-Hour Analog Classroom Study

This randomized, double-blind, placebo-controlled, analog study assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.

The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives were to assess the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D, SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.

In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. VYVANSE treatment was associated with significant improvement in behavior and attention as measured by both subjective (SKAMP-D) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day.

When measured using the PERMP scales, VYVANSE demonstrated significant improvement in math problems attempted and answered correctly with improvement for up to 13 hours post-dose.

Safety was also evaluated during the study and VYVANSE was gene
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SOURCE Shire plc
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