CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from a 26-week Phase 3 clinical trial assessing the efficacy and safety of the investigational drug linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). Analyses of the data indicate a statistically significant improvement (p<0.0001) was achieved for linaclotide-treated patients compared to placebo-treated patients on all four primary endpoints, which included two composite responder endpoints encompassing abdominal pain and complete spontaneous bowel movements (CSBMs), as well as individual responder endpoints for abdominal pain and CSBMs. Significant improvement (p<0.001) was also achieved for linaclotide-treated patients compared to placebo-treated patients on all pre-specified secondary endpoints, which were measures of abdominal pain, abdominal discomfort, bloating, and bowel symptoms. Both primary and secondary endpoints were assessed over the first 12 weeks of the treatment period, and these results were consistent with the first Phase 3 trial of linaclotide in patients with IBS-C.
