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news.Ironwood Pharmaceuticals and Forest Laboratories have announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for linaclotide to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
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Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine.
The NDA for linaclotide was submitted for the treatment of IBS-C and CC following efficacy and safety results from a Phase 3 program.
The program, which included four double-blind placebo-controlled trials and two open-label long term safety studies, enrolled over 2,800 patients received a once-daily dose of either linaclotide or placebo.