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New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)
Date:5/22/2009

PHILADELPHIA, May 22 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced results of a study showing that coadministration of the ADHD medication VYVANSE(R) (lisdexamfetamine dimesylate) CII with the proton pump inhibitor (PPI) Prilosec OTC(R) 40 mg (20 mg X 2), did not alter the median time it took for maximum plasma concentration of d-amphetamine to be reached in the subjects evaluated. In the same study, coadministration of Prilosec OTC with ADDERALL XR resulted in a nearly 45 percent reduction in the median time to reach maximum plasma concentrations of amphetamine, the active medication. Other pharmacokinetic parameters (maximum plasma concentration and area under curve) of active medication were not altered for either VYVANSE or ADDERALL XR when coadministered with Prilosec OTC. This study, which is the first to evaluate the pharmacokinetics of VYVANSE and ADDERALL XR taken alone and with Prilosec OTC 40 mg, was recently presented at the International Congress on Clinical Pharmacy, co-sponsored by the American College of Clinical Pharmacy (ACCP), in Orlando, FL.

"Since its approval for ADHD in adults in 2008, VYVANSE has been an important treatment option for physicians treating adult patients seeking significant ADHD symptom control during their busy day," said Jeffrey Jonas, Senior Vice President of Research & Development for the Specialty Pharmaceuticals business at Shire. "This study is the first to evaluate the impact of a proton pump inhibitor on the amphetamine pharmacokinetics of VYVANSE and ADDERALL XR and further supports that, as a prodrug, VYVANSE does not rely on pH for its absorption or conversion."

Heartburn is a common problem affecting millions of Americans. Prilosec OTC and other proton pump inhibitors
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SOURCE Shire plc
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