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news.Ironwood Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide used to treat irritable bowel syndrome with constipation (IBS-C).
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Linaclotide is a guanylate cyclase type-C (GC-C) agonist.
The company provided its efficacy and safety data from a Phase 3 program comprising two double-blind placebo-controlled trials.
Over 1,600 patients with IBS-C received a once-daily dose of either linaclotide or placebo and demonstrated improvements in abdominal and bowel symptoms for linaclotide treatment as compared to placebo treatment.
The study also revealed that diarrhea was the most commonly reported adverse event and led to study discontinuation in 5% of linaclotide-treated patients compared to fewer than 1% of patients receiving placebo.