Safety and Efficacy Results Presented From Largest Prospective Controlled Clinical Study of Ulcerati...(as efficacious and non-inferior to the40...),Health

Date:5/20/2008

as efficacious and non-inferior to the 400 mg mesalamine tablet dosed at 2.4 g/day. At Week 6, overall improvement was achieved by 70 percent of patients with moderately active UC on the investigational 800 mg mesalamine tablet (dosed at 4.8 g/day). Overall improvement was determined by clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy.

"These promising data presented at DDW will hopefully support the approval of a new treatment option for patients with moderately active ulcerative colitis," said David Lacy, GI category director for Procter & Gamble. "As a company, we are committed to GI research that will help us offer patients new treatment options and further advance understanding of how to best manage various GI conditions that negatively impact the lives of millions of people every day."

Additional Study Details

An oral presentation on May 20 announced findings from ASCEND III, a Phase III, 6-week, double-blind, randomized, multi-national, active-control study designed to evaluate the non-inferiority of the investigational 800 mg tablet dosed at 4.8 g/day versus the 400 mg mesalamine tablet dosed at 2.4 g/day in patients with moderately active UC (Physician's Global Assessment [PGA] = 2). The primary endpoint was overall improvement defined as improvement from baseline at six weeks in the PGA (which was based on the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy) and no worsening in any of the individual clinical assessments. A total of 772 patients were randomized and dosed. The primary objective of non-inferiority was met and overall improvement was seen in 70 percent (273/389) of patients receiving the 800 mg tablet dosed at 4.8 g/day as compared to 66 percent (251/383) of patients receiving the 400 mg tablet dosed at 2.4g/day. In the study the investigational 800 mg tablet dosed at 4.8 g/day also demonstrated efficacy in secondary endpoints: clinical remission, rectal bleeding, stoo
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