Ironwood and Forest Submit New Drug Application for Linaclotide
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.
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. announced Tuesday their submission of a New Drug Application (NDA) to the U.S. 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).
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.
A total of 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 these trials, statistically significant improvements in
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