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Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
Date:10/7/2008

udy's primary endpoint-was clinically and statistically significant (2.5 to 3.6 vs. 1.0; p = 0.0036 to <0.0001). In addition, abdominal pain was clinically and statistically significantly reduced in all linaclotide treatment groups compared to placebo (-0.7 to -0.9 change from baseline on a 5-point ordinal severity scale vs. -0.5; p = 0.0239 to <0.0001) and, in the 26 percent of patients with severe/very severe baseline abdominal pain, improvement was even more pronounced (-0.8 to -1.3 v -0.2; p = 0.0236 to <0.0001). Results for spontaneous bowel movement (SBM) frequency, stool consistency, straining, abdominal discomfort, bloating, IBS symptom severity, and global assessments were statistically significant for the 300 ug and 600 ug dose groups and for at least one of the two lower doses for each endpoint. Treatment effects of linaclotide were rapid in onset (within the first week of treatment) and were maintained throughout the entire 12-week treatment period; there was no indication of rebound clinical effects following cessation of treatment. Linaclotide was well tolerated at all doses with no treatment-related serious adverse events. The most common adverse event was diarrhea; however, there were no associated dehydration or electrolyte abnormalities. Diarrhea resulted in the discontinuation of 1 percent to 7 percent of linaclotide-treated patients and none of the placebo-treated patients.

This study was part of a larger Phase 2 program investigating the effect of linaclotide treatment on patients with IBS-C or chronic constipation (CC). Ironwood and Forest previously announced the results from the Phase 2b CC study and have initiated two pivotal Phase 3 CC trials and expect to initiate two pivotal Phase 3 IBS-C trials by January 2009.

IBS-C Phase 2b Study Design

This North American-based, randomized, multi-center, double-blind, placebo-controlled, dose-range-finding, parallel-group Phase 2b study was designed to assess the safety, efficacy,
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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals
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