Will FDA Push Through New Constipation Drug?

Two publicly traded companies announced at the close today that they are pursuing U.S. Food and Drug Administration approval for constipation drug linaclotide. The companies, Ironwood Pharmaceuticals IRWD and Forest Laboratories FRX, have finished Phase 3 trials reaching across 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 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 percent to 5 percent of linaclotide-treated patients compared to fewer than 1 percent 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. The drug is designed to treat two illnesses: Irritable Bowel Syndrome with Constipation About Irritable Bowel Syndrome with Constipation and Chronic Constipation. nearly 50 million people suffer from one or both of these illnesses.