Ironwood (IRWD), Forest (FRX) Submit NDA for Linaclotide to FDA
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Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced they have recently 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). 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 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.
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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.
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