Ironwood, Forest Labs Drug for Chronic Constipation Passes Two Pivotal Trials
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considered a patient a “responder” if he or she reported at least three complete, spontaneous bowel movements per week, and an increase of at least one of those bowel movements per week over a baseline period for at least nine weeks during the 12-week treatment period.
In the first study, about 16 percent of patients on a low dose of linaclotide achieved that definition of success, while 21.3 percent did that well on a higher dose, compared with about 6 percent of patients taking a placebo, the companies said. The second study found the low dose was actually slightly better than the high dose (21.2 versus 19.4 percent response rates), compared to 3.3 percent in the placebo group.
While that might not sound like an amazing response rate for the drug, these patients sound they were feeling pretty bad entering the study. During that two-week baseline period of the study, 72 percent of the patients had no complete, spontaneous bowel movements. The medical term is defined as when a patient reports they felt a complete emptying of the bowel.