*Patients who experience recurrence can be retreated up to two times.1
†Median of 10 weeks (range of 6 to 24 weeks).1
In adults with IBS-D
Just 2 weeks of XIFAXAN provided significant relief from both abdominal pain and diarrhea1,2*‡
TARGET 1 & 21,2‡
Two identical, randomized, phase 3, double-blind, placebo-controlled trials conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS were to receive XIFAXAN 550 mg 3 times a day (n=624) or placebo (n=634) for 14 days. Primary endpoint was adequate relief of IBS signs and symptoms for at least 2 of 4 weeks during the month following 14 days of treatment, with adequate relief 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].” Primary endpoint: 41% of patients (254 of 624) in the XIFAXAN 550 mg group, 31% of TARGET 1 placebo group (98 of 314) P=0.01 and 32% of TARGET 2 placebo group (103 of 320) P=0.03 experienced adequate relief of IBS signs and symptoms. Composite endpoint was defined as ≥30% decrease from baseline in abdominal pain with a weekly mean stool consistency score of <4 (loose stool) for ≥2 weeks during the month following 2 weeks of treatment. Composite endpoint: 47% of patients (291 of 624) in the XIFAXAN 550 mg group, 39% of TARGET 1 placebo group (121 of 314) P=0.04 and 36% of TARGET 2 placebo group (116 of 320) P=0.02 experienced symptom improvement based on the composite endpoint.
Just 2 weeks of XIFAXAN provided significant relief for up to 6 months1*†¶
TARGET 31¶
- †Median time to symptom recurrence was 10 weeks1
(range of 6 to 24 weeks)
- *Patients who experience recurrence can be retreated up to two times1
XIFAXAN was evaluated in 2438 IBS-D patients. 44% (n=1074) experienced relief from an open-label course of treatment. Relief was defined as experiencing a ≥30% improvement from baseline in the weekly average abdominal pain score (based on daily self-reports) and a ≥50% reduction in the number of days in a week with a daily stool consistency of Bristol Stool Scale type 6 or 7 (mushy or watery) compared with baseline. If patients experienced a recurrence of either of their symptoms for 3 weeks of a rolling 4-week period, they entered the randomized, double-blind treatment phase. Randomized patients then received a repeat treatment with either XIFAXAN or placebo. The primary endpoint was the proportion of patients who experienced relief in both symptoms (defined exactly as in the open-label period) during the 4 weeks following repeat treatment.
For continued relief, some patients may need additional treatment
Recurring symptoms were less severe than baseline1,3
TID = three times daily.
Change from baseline in mean daily global IBS symptom score during the first and second repeat treatment double-blind phases.
aStatistically significant difference versus placebo (least squares mean data). Data were analyzed using last observation carried forward methodology.
See XIFAXAN safety profile