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FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Date:6/1/2009

our study for patients taking VYVANSE during the double-blind treatment period, which were greater than or equal to 2 percent, were insomnia, decreased appetite, and anorexia.

VYVANSE Demonstrated Significant Efficacy Versus Placebo at 13 Hours Postdose

The study that led to this approval of revised labeling for VYVANSE 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. Further, VYVANSE treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0 and 12.0 hours).

Safety was also evaluated during the stu
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SOURCE Shire plc
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