NDA Accepted for Linaclotide for IBS-C and Chronic Constipation

The FDA has accepted for review the New Drug Application (NDA) for linaclotide (Forest and Ironwood) for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The companies submitted the NDA for linaclotide for the treatment of IBS-C and CC based upon efficacy and safety results from a Phase 3 program comprising four double-blind placebo-controlled trials and two open-label long term safety studies. A total of more than 2,800 patients received a once-daily dose of either linaclotide or placebo across the four clinical trials: two trials in patients with IBS-C and two trials in patients with CC.

Linaclotide, an investigational drug, is an orally delivered peptide that acts locally as an agonist of the guanylate cyclase type-C receptor located on the luminal surface of the intestine. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate, which is also believed to modulate the activity of local nerves to reduce pain.

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