FOREST LABS INC
			Symbol			FRX

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Ironwood and Forest Announce Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation

2009-11-02 21:52 ET - News Release

Top-line Results Show Each Trial Met Primary and All Secondary Endpoints

CAMBRIDGE, Mass. & NEW YORK -- (Business Wire)

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC). Analyses of the data indicate that in both multicenter, randomized, double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each trial (133 mcg/day: p-values≤0.0012 and 266 mcg/day: p-values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.

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