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Vyvanse Capsules CII administration through 2 routes demonstrated similar pharmacokinetic profile
Date:10/22/2009

PHILADELPHIA October 22, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally. Specifically, the overall rate and extent of exposure to d-amphetamine, the active medication in Vyvanse, was similar in healthy adults whether they received the drug as a solution through the nose or orally as a capsule. These findings, which were recently presented at a major psychiatric meeting, reflect the ongoing efforts of Shire to further understand the abuse potential of Vyvanse.

"This research is important because the route of administration of a drug may affect the rate and extent of absorption, which in turn may affect the risk of abuse. However, in this study, absorption of Vyvanse through the nose did not result in a rapid rise in d-amphetamine levels," said Patrick Martin, MD, Vice President, Global Clinical Pharmacology and Pharmacokinetics at Shire. "In this study, exposure to d-amphetamine did not differ when Vyvanse was administered orally or intranasally. While the results of this study are important, it is not accurate to say or imply that Vyvanse cannot be abused."

Vyvanse is indicated for oral administration only, and should not be administered intranasally.

About Vyvanse Vyvanse, which is approved to treat ADHD in children aged 6 to 12 years and in adults, 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 GI t
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Contact: Matthew Cabrey, Shire
484-595-8248
Porter Novelli
Source:Eurekalert

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