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Safety and Efficacy Results Presented From Largest Prospective Controlled Clinical Study of Ulcerative Colitis
Date:5/20/2008

4.8 g/day dose using investigational 800 mg tablet demonstrated efficacy

and was well tolerated in ASCEND III study

SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- In a study presented today at the 39th Annual Digestive Disease Week (DDW) meeting in San Diego, California, 70 percent of patients with moderately active ulcerative colitis (UC) receiving an investigational 800 mg mesalamine tablet dosed at 4.8 g/day under development by Procter & Gamble Pharmaceuticals experienced overall improvement in disease measures. In the study, the investigational tablet and dose were compared to 400 mg mesalamine tablets dosed at 2.4 g/day.

Additionally, patients in the study with a clinical history of more difficult-to-treat disease, such as those who have been previously treated with steroids and/or rectal therapies, received benefit from the investigational 800 mg tablets dosed at 4.8 g/day. Adverse events seen with the investigational 800 mg tablet dosed at 4.8 g/day were comparable to the 400 mg tablet dosed at 2.4 g/day and the discontinuation rate due to adverse events was no different between the two treatments (both 3.9 percent).

"The ASCEND III study is important because it helps us understand which patients may benefit from higher doses of mesalamine," says Dr. Stephen Hanauer, professor of medicine and clinical pharmacology chief, The University of Chicago Medical Center. "In this study the investigational 800 mg mesalamine tablet dosed at 4.8 g/day was well-tolerated and helped patients with moderately active UC manage their symptoms."

The ASCEND III study, which was discussed during an oral presentation at DDW today, was designed to further evaluate the clinical benefit of the investigational 800 mg tablet dosed at 4.8 g/day by assessing the non-inferiority of the 4.8 g/day dose versus the 2.4 g/day dose (400 mg mesalamine tablets). The primary endpoint was met -- the investigational 800 mg tablet dosed at 4.8 g/day w
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SOURCE Procter & Gamble
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