Linzess: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 1,223 CIC patients showed that once-daily 72 ug oral linaclotide for 12 weeks met the primary endpoint of improving overall responder rate, defined as having >=3 CSBMs per week and an increase of >=1 CSBM from baseline in the same week for >=9 of 12 weeks, vs. placebo. A pre-specified sensitivity analysis showed that linaclotide also significantly improved the durable overall responder rate, defined as overall responders who also had an increase of >=1 CSBM from baseline in the same week for >=3 of the last 4 weeks, vs. placebo. ...