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Study Showed VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment
Date:7/1/2009

ts taking VYVANSE compared to placebo. The key secondary efficacy measure was to assess the duration of efficacy of VYVANSE compared to placebo using PERMP; the PERMP total score is the sum of the number of math problems attempted (PERMP-A) plus the number of math problems answered correctly (PERMP-C) in a 10-minute session. Patients took the PERMP test one half hour before their first dosing and then at 2, 4, 8, 10, 12, and 14 hours after dosing at two visits (visits 5 and 6) during the double-blind crossover phase.

VYVANSE demonstrated significant improvement in the average total PERMP scores, 312.9 for the VYVANSE group compared to 289.5 for the placebo group; P<.0001. Also, at each postdose assessment from two hours to 14 hours, the VYVANSE group had significantly better average PERMP total scores than the placebo group, (P<.01 for all). At the first time point measured, two hours postdose, the average change from predose measurement in total PERMP scores for the VYVANSE group was 41.5 versus 22.5 for the placebo group; P<.001.

In addition to PERMP, the investigators measured the efficacy of VYVANSE using the ADHD-RS with adult prompts, which is a standardized test for assessing symptoms of ADHD and for assessing response to treatment. This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APA's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a publication of the American Psychiatric Association. In this study, VYVANSE demonstrated a reduction (approximately 52 percent) from baseline in average ADHD-RS total scores in adults, from 37.2 at baseline to 18.1 at visits 5 and 6. Adult patients taking placebo also demonstrated a reduction (approximately 21 percent) in average ADHD-RS total scores, from 37.2 at baseline to 29.6 at visits 5 and 6.

The study also assessed the safety of VYVANS
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SOURCE Shire plc
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