Linzess: Phase III data

Top-line data from a double-blind, international Phase III trial in 839 adult IBS-C patients showed that once-daily 290 ug oral linaclotide met the co-primary endpoints of improving Abdominal Pain/Discomfort Responder rate (60% vs. 48.8%, p=0.001) and IBS Degree of Relief Responder rate at week 12 vs. placebo (31.7% vs. 15.4%, p<0.0001). Additionally, a significantly greater proportion of patients receiving linaclotide achieved a >=30% reduction from baseline in abdominal pain and an increase of >=1 complete spontaneous bowel movement (CSBM) from baseline in the same week for >=6 of 12 weeks vs. placebo (33.7% vs. 17.4%, p<0.0001). Linaclotide also met the secondary endpoints of improving abdominal pain, abdominal discomfort, bloating, straining, frequency of CSBMs, frequency of spontaneous bowel movements (SBMs) and stool consistency vs. placebo. Early next year, Ironwood and AZ plan to submit a regulatory application in China for linaclotide to treat IBS-C. ...