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news.Shire has submitted a supplemental new drug application to the FDA for its Vyvanse drug for the treatment of ADHD in adults. The application is subject to a 10-month FDA review period.
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Vyvanse is a prodrug stimulant that is therapeutically inactive until metabolized in the body and active d-amphetamine is released. Shire says the drug is different from other oral long acting stimulants of amphetamine and methylphenidate that rely on delivery systems which may be affected by pH and GI transit time.
The company plans to announce full results from its phase III clinical trial for the treatment of ADHD in adults at a major scientific conference in Q4 2007.
The FDA approved Vyvanse on February 23, 2007, to treat symptoms of ADHD in children aged six to 12.