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Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration
Date:11/29/2007

Published Results Also Show Potentially Differentiating Pharmacokinetic

Profile of Prodrug Stimulant

PHILADELPHIA, Nov. 29 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced that Biological Psychiatry published the results of a study showing VYVANSE(TM) (lisdexamfetamine dimesylate), the first prodrug stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), provided significant efficacy in children for up to 12 hours. The published study also found that VYVANSE demonstrated low interpatient variability of measured pharmacokinetic parameters, as reported by the coefficient of variance (%CV).

This phase II randomized, double-blind, placebo- and active-controlled crossover analog classroom study in children aged 6 to 12 examined the efficacy and safety of VYVANSE (30 mg, 50 mg or 70 mg) and Adderall XR (mixed amphetamine salts extended-release: 10 mg, 20 mg or 30 mg) compared with placebo.

"This newly published research shows that VYVANSE provided a consistent time to maximum plasma concentration from patient to patient," said Ann S. Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, Nev. "This prodrug stimulant also demonstrated significant efficacy up to 12 hours after administration, which is something that my patients' parents are interested in as it may help to improve their family and homework time in the evening."

VYVANSE 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. Release of the active ingredient in VYVANSE does not rely on gastrointestinal factors such as gastrointestinal transit time and gastric pH.

Study Results Showed that VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours
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SOURCE Shire plc
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