†Targets 1 & 2 Study Design1,5: Two identical, randomized, phase 3, double-blind, placebo-controlled trials were conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS were randomized to receive XIFAXAN 550 mg 3 times a day (n=624) or placebo (n=634) for 14 days. Primary endpoint: 41% (n=254) of patients in both XIFAXAN 550 mg groups and 31% and 32% (n=201) of patients in the placebo groups experienced adequate relief of IBS signs and symptoms for at least 2 of 4 weeks during the month following 14 days of treatment; P<0.05 vs placebo. Adequate relief was defined as a response of “yes” to the weekly Subject Global Assessment (SGA) question: “In regards to your IBS symptoms, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No].” Composite endpoint: 47% (n=291) of patients in both XIFAXAN 550 mg groups and 39% in Target 1 and 36% in Target 2 (n=237) of patients in the placebo groups experienced a ≥30% decrease from baseline in abdominal pain for ≥2 weeks during the month following 2 weeks of treatment and had a weekly mean stool consistency score of <4 (loose stool) for ≥2 weeks during the month following treatment; P<0.05 for TARGET 1, P<0.01 for TARGET 2.
‡P<0.001 represents pooled data.1