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FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
Date:5/4/2010

ts, as measured by average PERMP total scores over the course of one assessment day, as well as at each time point measured.  The PERMP assessments were administered at predose (-0.5 hours) and at two, four, eight, 10, 12, and 14 hours postdose.

In addition to PERMP, the investigators measured the efficacy of Vyvanse using the ADHD-RS with adult prompts.  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 end point.  Adult patients taking placebo demonstrated a reduction (approximately 21 percent) in average ADHD-RS total scores, from 37.2 at baseline to 29.6 at end point.

The most frequently reported treatment-emergent adverse events reported by five or more percent of patients during the dose-optimization phase were decreased appetite, dry mouth, headache, insomnia (trouble sleeping), upper respiratory tract infection, irritability, nausea, anxiety, anorexia, diarrhea, and fatigue.

About Vyvanse

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Vyvanse is a therapeutically inactive prodrug stimulant in which d-amphetamine is covalently bonded to l-lysine.  After oral ingestion, it is converted to pharmacologically active d-amphe
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