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.