For the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in adults, the rate of composite response was numerically greater with VIBERZI than with placebo at 3 and 6 months. VIBERZI responders had dual-symptom relief.
Patients had simultaneous improvement in both abdominal pain and diarrhea as seen in two Phase 3 clinical trials1,2
IBS-3002 (N=1145) measured VIBERZI 100 mg (recommended dose) (n=382) vs placebo (n=382). Primary endpoint: Weeks 1-12: Trt Diff 13%, 95% CI (8%, 19%); P<0.001
In study IBS-3001,1 Significantly more viberzi 100 MG-treated patients were responders vs placebo AT 3 MONTHS
Primary endpoint: Weeks 1-12: 25% vs 17% with placebo. Weeks 1-26: 29% vs 19% with placebo
VIBERZI provided lasting relief of both abdominal pain and diarrhea in IBS-D.
Relief of both symptoms was maintained throughout treatment1,2
In clinical trials, the proportion of patients who were combined responders to VIBERZI at each 4-week interval was numerically higher than placebo as early as Month 1 through Month 61
Data from a randomized, parallel-group, multicenter, multinational, double-blind, placebo-controlled, Phase 3 clinical trial in IBS-D adult patients aged 18-80 years. Graphs depict response rate for study population at each monthly interval (additional analyses).1,2
VIBERZI, taken twice daily, was associated with reduced symptoms of IBS-D at 6 months.1,2
All patients met Rome III criteria for IBS-D (ie, a history of recurrent abdominal pain accompanied by frequent loose or watery stools)1,3
Recurrent abdominal pain or discomfort† on at least 3 days per month in the last 3 months associated with 2 or more of the following:
Objective
Study Design
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VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
VIBERZI is contraindicated in patients:
The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
Please see full Prescribing Information.
VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
VIBERZI is contraindicated in patients:
The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
Please see full Prescribing Information.