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Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
Date:5/20/2008

- Data being presented today at Digestive Disease Week -

CAMBRIDGE, Mass. and NEW YORK, May 20 /PRNewswire-FirstCall/ -- Ironwood Pharmaceuticals, Inc. (formerly Microbia, Inc.) and Forest Laboratories, Inc. (NYSE: FRX) today announced the presentation of data from a Phase 2b randomized, double-blind, placebo-controlled study assessing the safety and efficacy of linaclotide in patients with chronic constipation (CC). Analysis of these data indicate that linaclotide met its primary endpoint. The study results are being presented today at the Digestive Disease Week conference in San Diego by Anthony Lembo, M.D. of the Beth Israel Deaconess Medical Center in Boston.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

In the four-week study, once-daily doses of linaclotide -- 75 mcg, 150 mcg, 300 mcg, or 600 mcg -- were compared to placebo. The primary endpoint was the change from pre-treatment in weekly spontaneous bowel movement (SBM) frequency. During the two-week pre-treatment period, the mean baseline weekly SBM frequency rate for the intent-to-treat (ITT) population (n = 307) across all treatment groups was 2.3. Patients in the ITT population who received once-daily dosing of linaclotide demonstrated a statistically significant change in weekly SBM frequency of 2.6 (75 mcg, p < 0.05), 3.3 (150 mcg, p < 0.01), 3.6 (300 mcg, p < 0.001), and 4.3 (600 mcg, p < 0.001) compared to 1.5 for patients receiving placebo. Increases in SBM frequency were dose-related. At all doses above 75 mcg, linaclotide-treated patients also experienced statistically significant improvements in complete spontaneous bowel movement (CSBM) frequ
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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals
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