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Article: Ironwood and Forest Announce Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation.
- Article from:
- Clinical Trials Week
- Article date:
- November 16, 2009
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Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) 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
"The results of these two trials confirm the potential for ...