Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VYVANSE? (lisdexamfetamine dimesylate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults.
This application is subject to a 10-month FDA review period.
?ADHD is a treatable disorder that affects adults as well as children,? said Matthew Emmens, Shire Chief Executive Officer. ?We are pleased with the results of VYVANSE studies conducted in adults and we believe this product will meet an important need in the adult ADHD marketplace. VYVANSE is a priority in our ADHD portfolio and we are committed to developing this next generation ADHD medication so that adults diagnosed with ADHD may benefit from treatment with VYVANSE.?
VYVANSE 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 GI transit time.
Shire 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 6 to 12.
Academic difficulties are also frequent. The symptoms are especially difficult to define because it is hard to draw a line at where normal levels of inattention, hyperactivity, and impulsivity end and clinically significant levels requiring intervention begin. To be diagnosed with ADHD, symptoms must be observed in two different settings for six months or more and to a degree that is greater than other children of the same age.