Ironwood, AZ planning Chinese NDA for linaclotide

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said linaclotide met the co-primary endpoints in a Phase III trial conducted primarily in China to treat irritable bowel syndrome with constipation (IBS-C). The partners plan to submit an NDA in early 2016 to the China Food and Drug Administration (CFDA).

The 839-patient trial's co-primary endpoints were abdominal pain or discomfort response and IBS degree of relief response. Among patients receiving linaclotide, 60% had at least a 30% improvement in abdominal pain or discomfort for at least half of the 12-week treatment period, vs. 48.8% of patients who received placebo (p=0.001). Additionally, 31.7% of linaclotide patients rated their IBS symptoms as "considerably relieved" or "completely relieved" for at least half of the treatment period vs. 15.4% on placebo (p<0.0001). ...