Learn All About How XIFAXAN Helps Treat IBS-D

What is XIFAXAN (zī-fax-an)?

Xifaxan is a prescription treatment that helps you find relief from IBS-D symptoms of abdominal pain and diarrhea. It's the only FDA-approved two-week treatment for IBS-D.* With a short term treatment period and lasting relief, you can stop worrying about when your symptoms will strike^† and start focusing on what matters.^†

IBS-D = irritable bowel syndrome with diarrhea. *In a clinical trial: range of 6 to 24 weeks; average of 10 weeks. ^†You can be retreated up to two times if symptoms come back.

Proven relief from both abdominal pain and diarrhea

Just two weeks of Xifaxan provided significant relief in adults with IBS-D

of patients saw relief
from abdominal pain

compared to 43% placebo

of patients saw relief
from diarrhea

compared to 66% placebo

of patients saw relief
from abdominal pain
and diarrhea

compared to 37% placebo

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. Composite endpoint: 47% of patients (291 of 624) in the XIFAXAN 550 mg group, 39% of TARGET 1 placebo group (121 of 314) and 36% of TARGET 2 placebo group (116 of 320) experienced symptom improvement based on the composite endpoint.

Short-term treatment, long term relief

After just two weeks of treatment, relief lasted for up to 6 months^*

^*In a clinical trial: range of 6 to 24 weeks; average of 10 weeks.
^†You can be retreated up to two times if symptoms come back

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) compared with baseline. 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.

Ask your doctor if XIFAXAN is right for you.

2-week treatment for up to 6 months of significant relief^*†

*In a clinical trial: range of 6 to 24 weeks; average of 10 weeks.
^†You can be retreated up to two times if symptoms come back.

There’s a different way to treat IBS-D

Unlike other IBS-D treatments, XIFAXAN is a short course therapy, without needing to take a continuous daily pill. XIFAXAN is a 2 week treatment that provides up to 6 months of relief from IBS-D symptoms. XIFAXAN works mainly in the gut to inhibit the growth of bacteria.*^†

In clinical trials, patients reported that recurring symptoms were less severe than when they first started on XIFAXAN. Patients with recurring symptoms were treated with XIFAXAN up to 2 times.

How does XIFAXAN treat IBS-D?

The exact cause of IBS-D is unknown. However, it is believed that an imbalance in gut bacteria may lead to IBS-D symptoms.

XIFAXAN works mainly in the gut to inhibit the growth of bacteria.

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.

Most common side effects

In clinical studies, the most common side effects associated with XIFAXAN for IBS-D were:

• Nausea (feeling sick to your stomach)
• An increase in liver enzymes

Taking XIFAXAN

XIFAXAN is a short-term treatment that you take 3 times a day for 2 weeks

Follow your doctor’s instructions exactly when taking XIFAXAN

XIFAXAN tablets can be taken with or without food

Talk to your doctor about XIFAXAN

$0 copay available for eligible commercially insured patients with coverage for Xifaxan

X

ABOUT XIFAXAN

ABOUT XIFAXAN

What is XIFAXAN (zī-fax-an)?

Proven relief from both abdominal pain and diarrhea

Just two weeks of Xifaxan provided significant relief in adults with IBS-D