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Title: Asacol Induced Rapid Mucosal Healing in Ulcerative Colitis Patients

"Asacol Induced Rapid Mucosal Healing in Ulcerative Colitis Patients"

LOS ANGELES, C.A. -- May 30, 2006 -- A new data analysis shows that Asacol(R) (mesalamine) delayed-release 400 mg tablets (2.4 g/day) and investigational 800 mg mesalamine tablets (4.8 g/day) induced endoscopically measured mucosal healing in patients with moderately active ulcerative colitis (UC). These findings were presented at the annual Digestive Disease Week meeting, taking place in the Los Angeles Convention Center. Two treatment groups were analyzed, one given Asacol 2.4 g/day and the other given 4.8 g/day mesalamine. In as early as three weeks, 65% of patients taking 4.8 g/day mesalamine experienced mucosal healing. By six weeks, 80% of these patients experienced mucosal healing. In the lower dose group, 58% of patients experienced mucosal healing at three weeks and 68% by six weeks. According to the American College of Gastroenterology guidelines, the goals for treating active UC are to treat symptoms as well as mucosal inflammation. "With 68% of the patients with moderate UC achieving mucosal healing on Asacol 2.4 g/day by six weeks, an additional benefit has been demonstrated in a product that is already proven in efficacy with an excellent safety profile," said lead author, Gary R. Lichtenstein, MD, professor of medicine and Director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania in Philadelphia. "Mucosal healing has been a topic of interest in UC lately, now we have evidence that Asacol heals the mucosa" Dr. Lichtenstein said. The findings were presented in a poster titled "Endoscopically measured mucosal healing of delayed-release oral mesalamine 4.8 g/day versus 2.4 g/day." The analysis pooled data from two phase 2I, multi-center, randomized, double-blind, 6-week, controlled studies of similar design (ASCEND I and II). Mucosal healing was defined as endoscopy subscore of 0 or 1. Patients with moderately active UC (defined as a baseline Physician's Global Assessment score of 2) and baseline endoscopy subscore greater than or equal to 2 were included in this analysis. A total of 423 analyzable patients with moderate UC were randomized in the two studies, of which 391 patients met criteria for this analysis. About Ulcerative Colitis Ulcerative colitis involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease and in extent of the colon affected. Treatment depends on the severity of disease. It causes flares followed by periods of remission. During a flare, in which the rectum and/or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While ulcerative colitis is a lifelong condition, flares can be managed with medication. Ulcerative colitis affects people of all ages, but often is diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system. About Asacol(R) (mesalamine) Delayed-Release Tablets 400 mg Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets TID for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses). Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs 36%), abdominal pain (18% vs 14%), and eructation (16% vs 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs 50%), rhinitis (42% vs 36%), and diarrhea (35% vs 50%). Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. As with other mesalamine-containing products, serious adverse events may occur with Asacol. SOURCE: Procter & Gamble

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