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, 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 VYVANSE, finding that the most frequently reported adverse events (greater than or equal to 5 percent) for patients during the dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, and feeling jittery.
VYVANSE, which was introduced in the United States in July 2007 for the treatment of ADHD
|Contact: Matthew Cabrey (Shire North America)|