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Study Published in Child and Adolescent Psychiatry and Mental Health Demonstrated Once-Daily Vyvanse(R) (lisdexamfetamine dimesylate) CII Provided Significant Improvement of ADHD Symptoms for Children at 13 Hours After Administration
Date:7/22/2009

t treatment to have efficacy at 13 hours after administration for pediatric patients included in its product labeling.( )

"Shire is proud to be at the forefront of ADHD research and treatment development and is committed to providing patients with effective ADHD medications, such as Vyvanse," said Liza Squires, MD, Research and Development Business Unit Leader for Shire. "These findings provided further support that Vyvanse can be an important treatment option for children who require duration of ADHD symptom improvement throughout the day."

Vyvanse Demonstrated Significant Symptom Improvement at 13 Hours After Administration

The study was a randomized, double-blind, placebo-controlled, analog classroom study that 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 included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of Vyvanse compared with placebo as measured by 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
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SOURCE Shire plc
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