*In clinical trials, more patients taking XIFAXAN vs. placebo for 2 weeks had relief of IBS-D symptoms for 10 weeks following treatment. Median duration of symptom relief was 10 weeks (range of 6 to 24 weeks). You can be retreated up to 2 times if symptoms return. Individual results may vary. ‡Based on aggregated total of all prescribers as of June 2022. §The American College of Gastroenterology has given Xifaxan (rifaximin) a strong recommendation to treat global IBS-D symptoms. This is based on a moderate level of clinical trial data.
XIFAXAN 
Placebo
Relief from
abdominal pain and
diarrhea†
(n=291/624)
47%
(n=237/634)
37%
XIFAXANPlacebo
Relief from
abdominal pain
(n=324/624)
52%
(n=270/634)
43%
Relief from
diarrhea
(n=477/624)
76%
(n=418/634)
66%
In a pooled analysis of TARGET 1 and 2 clinical trials. Efficacy responder rates in TARGET trials 1 and 2 during the 10 weeks following 2 weeks of treatment. No rescue medication was allowed in these clinical trials.
†Composite endpoint.
*You can be retreated up to 2 times if symptoms return. Individual results may vary.
Two identical phase 3, randomized, double-blind, placebo-controlled trials were conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS-D were to receive XIFAXAN 550 mg 3 times a day (n=624) or placebo (n=634) for 14 days.
Primary endpoint: Adequate relief of IBS-D 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-D 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-D symptoms? [Yes/No].”
Primary endpoint results: 41% of patients (254 of 624) in the XIFAXAN 550 mg group, 31% of TARGET 1 trial placebo group (98 of 314), and 32% of TARGET 2 trial placebo group (103 of 320) experienced adequate relief of IBS-D signs and symptoms.
Secondary endpoint: In both studies, more patients in the XIFAXAN 550 mg group had adequate relief of global IBS-D symptoms (see primary endpoint for definition) within the first month compared with the placebo group. Relief continued during the first 2 months and throughout all 3 months in both studies.
Composite endpoint: ≥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.
Percentage of bloating responders based on weekly responses in a pooled analysis of TARGET 1 and 2 trials.
(n=251/624)
40%
(n=192/634)
30%
XIFAXAN Placebo
Key secondary endpoint: The proportion of subjects who achieved adequate relief of IBS-D related bloating (ie, responders) for at least 2 of 4 weeks during the month following 14 days of treatment. A bloating responder was defined as a patient who responded “yes” to the weekly questions: “In regards to your IBS-D symptom of bloating, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS-D symptom of bloating? [Yes/No].”||
Key secondary endpoint: The proportion of subjects who achieved adequate relief of IBS-D related bloating (ie, responders) for at least 2 of 4 weeks during the month following 14 days of treatment.
A bloating responder was defined as a patient who responded “yes” to the weekly questions: “In regards to your IBS-D symptom of bloating, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS-D symptom of bloating? [Yes/No].”||
||Responses were given during the first 4 weeks of the treatment-free period following 2 weeks of active treatment (primary evaluation period).
Percentage of urgency responders based on weekly responses in TARGET 1, 2 and 3 trials in a pooled post hoc analysis.
(n=251/624)
53%
(n=192/634)
43%
XIFAXAN Placebo
Secondary endpoint: Change from baseline to each week during the 12-week study duration for sense of urgency. An urgency responder was defined as a patient with a ≥30% decrease from baseline in the percentage of days with urgency for at least 2 of 4 weeks during the month following 14 days of treatment. Urgency was determined based on a patient response of “yes” to the daily question: “Have you felt or experienced a sense of urgency today? [Yes/No].”
Secondary endpoint: Change from baseline to each week during the 12-week study duration for sense of urgency.
An urgency responder was defined as a patient with a ≥30% decrease from baseline in the percentage of days with urgency for at least 2 of 4 weeks during the month following 14 days of treatment. Urgency was determined based on a patient response of “yes” to the daily question: “Have you felt or experienced a sense of urgency today? [Yes/No].”
Stool frequency (number of bowel movements per day) was assessed as a secondary endpoint, but there was no meaningful difference between XIFAXAN and placebo.
In a randomized repeat treatment study
of patients taking XIFAXAN experienced relief from a course of treatment
(n=1074/2438)had symptoms return (median time to recurrence was 10 weeks; range of 6 to 24 weeks)
(n=692/1074)of patients experienced significant improvement in abdominal pain and diarrhea
(n=125/328) vs. 31.5% for placebo (n=97/308)had no symptoms return within 6 months*
(n=328/1074)
*36% of open-label responders did not experience relapse during the 18-week observation phase before being withdrawn from the trial for any reason.
This trial included an open-label phase followed by a randomized, placebo-controlled phase, with the aim of determining the efficacy and safety of repeat treatment with XIFAXAN in patients with IBS-D who had responded to a 2-week course of XIFAXAN and subsequently experienced IBS-D symptom recurrence.
A responder was defined as a patient 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 Form Scale type 6 or 7 (mushy or watery) for ≥2 of the 4 weeks after treatment.
Recurrence was defined as the return of abdominal pain or lack of stool consistency for 3 weeks of a rolling 4-week period.
Primary endpoint: The proportion of patients who were responders to repeat treatment in both IBS-D related abdominal pain and stool consistency during the 4 weeks following the first repeat treatment course.
In a randomized repeat treatment study
of patients taking XIFAXAN experienced relief from a course of treatment
(n=1074/2438)had no symptoms return within 6 months*
(n=328/1074)
had symptoms return (median time to recurrence was 10 weeks; range of 6 to 24 weeks)
(n=1074/2438)
In a randomized repeat treatment study
of patients experienced significant improvement in abdominal pain and diarrhea
(n=125/328) vs. 31.5% for placebo (n=97/308)*36% of open-label responders did not experience relapse during the 18-week observation phase before being withdrawn from the trial for any reason.
This trial included an open-label phase followed by a randomized, placebo-controlled phase, with the aim of determining the efficacy and safety of repeat treatment with XIFAXAN in patients with IBS-D who had responded to a 2-week course of XIFAXAN and subsequently experienced IBS-D symptom recurrence.
A responder was defined as a patient 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 Form Scale type 6 or 7 (mushy or watery) for ≥2 of the 4 weeks after treatment.
Recurrence was defined as the return of abdominal pain or lack of stool consistency for 3 weeks of a rolling 4-week period.
Primary endpoint: The proportion of patients who were responders to repeat treatment in both IBS-D related abdominal pain and stool consistency during the 4 weeks following the first repeat treatment course.
Connect with a Nurse Navigator* to learn more about XIFAXAN or
explore more on your own.
Follow your healthcare provider’s instructions exactly when taking XIFAXAN
XIFAXAN comes in a tablet form for oral administration
XIFAXAN tablets can be taken with or without food
You can be retreated up to 2 times if symptoms come back
In clinical studies, the most common side effects with XIFAXAN for IBS-D were:
Constipation was observed in 0.3%-0.6% of patients treated with XIFAXAN.
†Nausea was observed in 3% of patients taking XIFAXAN vs 2% taking placebo.
‡Liver enzymes increase observed in 2% of patients taking XIFAXAN vs 1% taking placebo.
XIFAXAN is an antibacterial medication, or antibiotic, that did not cause any clinically relevant antibiotic resistance after 1 to 3 treatment cycles. If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
The exact cause of IBS-D is unknown. However, it is believed that an imbalance in gut bacteria may be linked to IBS-D symptoms. XIFAXAN works mainly in the gut to inhibit the growth of bacteria. Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
The American College of Gastroenterology (ACG), a leading authority in GI disorders, has given XIFAXAN (rifaximin) a strong recommendation to treat global IBS-D symptoms. This is based on a moderate level of clinical trial data.
If you want to learn more about the clinical data supporting the recommendation to see if XIFAXAN is right for you, talk to your healthcare provider.
Chat with a Nurse Navigator* to learn more about XIFAXAN or receive additional resources.
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