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news.Ironwood Pharmaceuticals and Forest Laboratories have filed new drug application (NDA) for linaclotide with the US Food and Drug Administration (FDA) as a treatment for patients with irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
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The submission of the NDA is based on the safety and efficacy data from a Phase 3 program consisting four double-blind placebo-controlled trials and two open-label long term safety studies.
The result from the trials suggested that the drug improves abdominal and bowel symptoms as compared to the placebo-treated patients.
The trials involved approximately 28,00 patients where the subjects were given once-daily dose of either linaclotide or placebo across the four placebo-controlled clinical trials.