FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD... (July 2007 the product has achieved a U.S...)

FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults

Date:4/23/2008

July 2007, the product has achieved a U.S. market share of 6.9 percent based on weekly branded prescription volume VYVANSE formulary coverage has been positive, with the top six managed care plans now covering the product in a preferred formulary position.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.

VYVANSE is currently available in three dosage strengths of 30 mg, 50 mg and 70 mg, each for once-daily dosing. Additional dosage strengths of 20 mg, 40 mg and 60 mg VYVANSE have also been FDA-approved and are expected to be available in pharmacies this summer.

Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.

VYVANSE Significantly Improved ADHD Symptoms

The phase III pivotal trial that led to the FDA approval of VYVANSE to treat adults with ADHD was a double-blind, placebo-controlled, four-week study with dose escalations in 414 adults aged 18 to 55 years. In this study, adults with ADHD experienced significant improvements in ADHD symptom control 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, providing a reduction in ADHD Rating Scale (ADHD-RS-IV) scores ranging from 16.2 to 18.6 points at endpoint. The ADHD-RS-IV is a standardized test for assessing symptoms of ADHD and for assessing their response to treatment. This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APAs Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a pu
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Contact: Matthew Cabrey, Shire
484-595-8248
Porter Novelli
Source:Eurekalert

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FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD...(July 2007 the product has achieved a U.S...),Health