Ironwood and Forest Announce Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation
November 02 2009 - 9:52PM
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
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