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Ironwood And Forest Present Positive Phase 2b Study Results For Linaclotide In Patients With Irritable Bowel Syndrome With Constipation

Ironwood Pharmaceuticals, Inc. (formerly Microbia, Inc.) and Forest Laboratories, Inc. (NYSE: FRX) announced the presentation of results from a Phase 2b study assessing linaclotide's safety and efficacy in 420 patients with irritable bowel syndrome with constipation (IBS-C). Analysis of the data indicates that once- daily oral dosing of linaclotide, across a range of doses, significantly reduced abdominal pain and significantly improved constipation symptoms in patients with IBS-C throughout the 12-week study period. Further, the safety and tolerability profile support advancing this novel compound into Phase 3 clinical trials. The study results were presented in a plenary session at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Fla.

"Patients with IBS-C are in need of effective and well tolerated therapies. The results of this study showing improvement in abdominal pain and constipation are encouraging," said Douglas Drossman, M.D., Professor of Medicine and Psychiatry at UNC School of Medicine, Division of Gastroenterology and Hepatology and Co-Director of the UNC Center for Functional GI & Motility Disorders, University of North Carolina at Chapel Hill, N.C.

Study Results

420 patients were randomized into the study and 337 completed the 12-week treatment period. At all linaclotide dose levels, the change from baseline vs. placebo for complete spontaneous bowel movement (CSBM) frequency-the study's primary endpoint-was clinically and statistically significant (2.5 to 3.6 vs. 1.0; p = 0.0036 to





Ironwood si forestiere Prezent pozitive Faza 2b Studiul Rezultate pentru Linaclotide la pacienþii cu Sindromul Irritable Bowel Cu constipaþie - Ironwood And Forest Present Positive Phase 2b Study Results For Linaclotide In Patients With Irritable Bowel Syndrome With Constipation - articole medicale engleza - startsanatate