Shire submits sNDA for Vyvanse to US FDA
UK drugmaker Shire has submitted a supplemental New Drug Application to the US Food and Drug Administration for Vyvanse (lisdexamfetamine dimesylate) for the treatment of attention-deficith hyperactivity disorder in adults. This application is subject to a 10-month review.
The agent is a prodrug stimulant that is therapeutically-inactive until metabolized in the body and active d-amphetamine is released. Vyvanse is different from other oral long-acting stimulants of amphetamine and methylphenidate that rely on delivery systems which may be affected by pH and gastrointestinal transit time.
Shire plans to announce full results from a Phase III clinical trial of the drug for the treatment of ADHD in adults at a major scientific conference in fourth-quarter 2007. The FDA approved Vyvanse on February 23 to treat symptoms of ADHD in children aged six to 12 years.
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