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Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD
Date:10/7/2008

allel-group, four-week study with dose escalations in 414 adults aged 18 to 55 years, adults with ADHD experienced significant improvements in ADHD symptoms within one week of treatment with once-daily VYVANSE.

Treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) was significantly more effective than placebo, with a mean reduction in ADHD Rating Scale (ADHD-RS-IV) scores (16.2 to 18.6 points; P<.0001); demonstrating a 40 to 45 percent decrease at endpoint. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a publication of the American Psychiatric Association.

Investigators also measured the efficacy of VYVANSE using the Clinical Global Impressions-Improvement (CGI-I) scale. On this scale, the percentage of adults taking VYVANSE rated by investigators as "much improved" or "very much improved" ranged from 57 to 61 percent at endpoint and was significantly greater than placebo (P<.01). The CGI-I is a standard assessment used to rate a patient's improvement over time.

The most common adverse events in the study were decreased appetite, difficulty falling asleep, and dry mouth.

"This study was one of the largest controlled stimulant trials in adults with ADHD, and these data reinforce the importance of VYVANSE as a new once-daily treatment option for adults with ADHD that significantly improved their ADHD symptoms," said Mike Cola, President of Shire's Specialty Pharmaceuticals business. "Shire recognizes the need for more research on ADHD in the adult population and is committed to advancing the science of ADHD and providing treatments that help children and adults diagnosed with ADHD to lead more productive lives."

VYVANSE is a therapeutically inactive prodrug, in which d-
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SOURCE Shire Limited
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