Think XIFAXAN FIRST
Short-term therapy.^1* Lasting relief.^1†

^‡TARGET 1 and 2 study design^1,2

Two identical Phase 3, randomized, 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 (n=624) or placebo (n=634) 3 times a day for 14 days.

Primary endpoint: 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 results: 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: ≥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.

• Primary endpoint: 38% experienced significant improvement in stool consistency and abdominal pain (n=125/328, P<0.05) vs 31% for placebo (n=97/308)
• *Patients who experience recurrence can be retreated up to two times¹
• ^†Median time to symptom recurrence was 10 weeks (range of 6 to 24 weeks)¹

^¶TARGET 3 study design^1,3

The primary focus was to assess response to treatment during an 18-week observation phase after initial 4-week follow-up (total of 22 weeks following 2-week treatment). If a patient responded to open-label treatment but later experienced a recurrence, they entered the randomized, double-blind retreatment phase. Randomized patients then received a repeat treatment with either XIFAXAN or placebo.

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 Scale type 6 or 7 (mushy or watery) for ≥2 weeks during the month following 2 weeks of 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 in the double-blind, placebo-controlled portion of the trial was the proportion of patients who were responders to repeat treatment in both IBS-related abdominal pain and stool consistency.

After initial relief, recurring symptoms were less severe than baseline^1,3#

TID = three times daily

Change from baseline in mean daily global IBS symptom score during the first and second repeat treatment double-blind phases. Global daily IBS-D symptoms score is based on a 6-question patient assessment related to bowel movement, urgency, pain, bloating, and severity of symptoms.

^#Baseline was defined as study entry into open-label phase.

^△Statistically significant difference versus placebo (least squares mean data). Data were analyzed using last observation carried forward methodology.