Here’s what you should know.
1. Regulatory agencies approved Linaclotide in Japan to treat irritable bowel syndrome with constipation and in the United States for IBS-C or chronic idiopathic constipation treatment.
2. In the phase III trial, patients received open-label linaclotide for an additional 52 weeks in an attempt to receive regulatory approval in Japan.
3. In the trial, 186 patients received either linaclotide or a placebo for four weeks. Patients showed a significant approval from those treated with the placebo. The most common adverse events were mild or moderate diarrhea.
4. This was the ninth consecutive trial in which linaclotide met its primary endpoints.
5. The trial was intended for linaclotide to earn approval, as a treatment for chronic idiopathic constipation in Japan.
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