Ironwood and Forest Laboratories Submit Linaclotide to FDA

Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc. have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linaclotide, a guanylate cyclase type?C (GC?C) agonist, for the treatment of irritable bowel syndrome with constipation (IBS?C) and chronic constipation (CC).

Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type?C (GC?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 submission includes efficacy and safety data from a Phase 3 program comprising four double?blind placebo?controlled trials and two open?label long term safety studies. More than 2,800 patients received a once?daily dose of either linaclotide or placebo across the four placebo?controlled clinical trials: two trials in patients with IBS?C and two trials in patients with CC.

In the trials, statistically significant improvements in abdominal and bowel symptoms were achieved for linaclotide?treated patients versus placebo?treated patients for all primary and
secondary endpoints. Safety data collected across the four placebo?controlled Phase 3 clinical trials demonstrated that diarrhea was the most commonly reported adverse event and led to study discontinuation in 4% to 5% of linaclotide?treated patients compared to fewer than 1% of patients receiving placebo.

Additionally, over 3,200 patients have enrolled in ongoing open?label safety studies and more than 1,100 of those patients have received linaclotide for at least 12 months.

Release Date: August 9, 2011
Source: Ironwood Pharmaceuticals, Inc.