*IBS-D = irritable bowel syndrome with diarrhea. †In a clinical trial: range of 6 to 24 weeks; average of 10 weeks of relief from abdominal pain and diarrhea. You can be retreated up to two times if symptoms come back. ‡Based on aggregated total of all prescribers as of December 2020.
Target 1 & 2 Study Design: Two identical, randomized, phase 3 trials conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS received 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. 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].” Primary endpoint: 41% of patients (254 of 624) in the XIFAXAN 550 mg group, 31% of TARGET 1 placebo group (98 of 314) and 32% of TARGET 2 placebo group (103 of 320) experienced adequate relief of IBS signs and symptoms. Composite endpoint was defined as ≥30% decrease from baseline in abdominal pain with a weekly average stool consistency score of <4 (loose stool) for ≥2 weeks during the month following 2 weeks of treatment.
*In a clinical trial: range of 6 to 24 weeks; average of 10 weeks of relief from abdominal pain and diarrhea. †You can be retreated up to 2 times if symptoms return.
Target 3 Study Design: XIFAXAN was evaluated in 2438 IBS-D patients. 44% (n=1074) experienced relief from a 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) for ≥ 2 weeks during the month following 2 weeks of treatment. If patients experienced a recurrence of either of their symptoms for 3 weeks of a rolling 4-week period, they were then randomized to receive 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 first treatment period) during the 4 weeks following repeat treatment.
Follow your doctor’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 only 0.5% of XIFAXAN patients.
†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.
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 doctor.
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.
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