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Shire Announces Top-line Results of the PREVENT2 Trial
Date:3/30/2012

items: abdominal pain, a 15% increase in white blood cell count from baseline, and bowel wall thickening (>5mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan, or 2) surgical intervention for diverticular disease. The key secondary endpoint evaluated recurrence based on CT scan only.[1] There were no new safety observations identified in the PREVENT2 trial.

About the PREVENT program

The PREVENT investigational program consists of two trials, PREVENT1 and PREVENT2. These are phase 3, randomized, double-blind, dose-response, stratified, placebo-controlled studies with an identical design. PREVENT2 randomized 592 subjects to receive once-daily SPD476, MMX mesalamine 1.2g, 2.4g or 4.8g, or placebo, over a period of 104 weeks.[1] The PREVENT1 trial results are expected later this year.

About SPD476, MMX mesalamine[2,3]

SPD476, MMX mesalamine is an anti-inflammatory drug, with each delayed-release tablet containing 1.2g of 5-aminosalicylic acid (5-ASA; mesalamine). In the U.S., SPD476, MMX mesalamine is registered as Lialda® (mesalamine) and is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. In Europe, it is registered as Mezavant®/Mezavant XL® and is approved for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis and for maintenance of remission. SPD476, MMX mesalamine should be taken once daily with food.[2,3]

MMX is a registered trademark of Cosmo Technologies, Ltd., Ireland.

IMPORTANT SAFETY INFORMATION

You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing pr
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SOURCE Shire plc
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