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Title: MMX Mesalazine Therapy Relieves Ulcerative Colitis Symptoms: Presented at UEGW

"MMX Mesalazine Therapy Relieves Ulcerative Colitis Symptoms: Presented at UEGW"

By Jill Stein PARIS, FRANCE -- October 29, 2007 -- MMX(TM) mesalazine provides resolution of rectal bleeding and high stool frequency in patients with ulcerative colitis (UC) within weeks of treatment initiation, researchers reported here at the 15th United European Gastroenterology Week (UEGW). Stefan Schreiber, MD, Professor of Medicine and Gastroenterology, Christian Albrechts Kiel University, Keil, Germany, and colleagues examined the time to initial resolution of rectal bleeding and normalisation of stool frequency in patients with mild to moderate UC who received MMX mesalazine (2.4 g/day or 4/8 g/day) or placebo for 8 weeks. The data were drawn from a pooled analysis of two phase 3 studies that had almost identical study designs and endpoints. A total of 517 patients were included in the intent-to-treat population. For the initial normalisation of stool frequency alone, median times were 19 days in the MMX mesalazine 2.4 g/day group and 20 days in the 4.8 g/day group, which was significantly shorter compared with the 34 days in the placebo group ([P =.00001).

For the initial resolution of rectal bleeding alone, median times were also significantly shorter in the MMX mesalazine groups compared with the placebo group (7 days, 8 days, and 16 days in the three groups, respectively).

Median time to initial resolution of symptoms was significantly shorter in the MMX mesalazine groups compared with the placebo group (25 days, 26 days, and 44 days, respectively (P =.0001).

Mean stool frequency and rectal bleeding scores decreased after treatment in all three groups; however, the changes in symptom scores were largest in the two MMX mesalazine groups.

Overall, the results showed that in most patients receiving MMX mesalazine, resolution of both major UC symptoms (as defined in this analysis) occurred within 4 weeks of therapy versus greater than 6 weeks for placebo, Dr. Schreiber said.

MMX mesalazine is a novel, once-daily, high-strength formulation of 5-aminosalicyclic acid (mesalazine, 1.2 g per tablet) that uses MMX technology to deliver 5-ASA throughout the colon. This delivery system uses lipophilic and hydrophilic excipients, which are believed to prolong exposure of the colonic mucosa to the 5-aminosalicyclic acid, enclosed within a gastro-resistant, pH-dependent coating.

Funding for this study was provided by Shire Pharmaceuticals.

[Presentation Title: MMX^TM Mesalazine Therapy for Active, Mild-to-Moderate Ulcerative Colitis: Time to Initial Symptom Resolution. Abstract Number G-359]

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