For the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in adults

VIBERZI RESPONDERS HAD SIGNIFICANT DUAL-SYMPTOM RELIEF

Patients had simultaneous improvement in both abdominal pain and diarrhea as seen in two Phase 3 clinical trials1,2

In this trial, nearly twice as many VIBERZI-treated patients were responders vs placebo at 3 months1

In an additional study (IBS-3001),1
Significantly more VIBERZI 100 mg-treated patients were responders vs placebo
Primary endpoint: Weeks 1-12: 25% vs 17% with placebo
Secondary endpoint: Weeks 1-26: 29% vs 19% with placebo

Data from two randomized, parallel-group, multicenter, multinational, double-blind, placebo-controlled, Phase 3 clinical trials in IBS-D adult patients aged 18-80 years. A responder was defined as a patient with ≥30% reduction in daily abdominal pain AND improvement in daily stool consistency to <5 on the Bristol Stool Scale. Improvement in abdominal pain in the absence of a bowel movement was also considered a response day. Responders saw simultaneous improvement of BOTH symptoms on at least 50% of days in the trial. 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. Secondary endpoint: Weeks 1-26: Trt Diff 13%, 95% CI (6%, 19%). IBS-3001 (N=1281) measured VIBERZI 100 mg (recommended dose) (n=426) vs placebo (n=427). Primary endpoint: Weeks 1-12: Trt Diff 8%, 95% CI (3%, 14%); P<0.01. Secondary endpoint: Weeks 1-26: Trt Diff 10%, 95% CI (5%, 16%).1

VIBERZI PROVIDED LASTING RELIEF OF BOTH ABDOMINAL PAIN AND DIARRHEA IN IBS-D

Relief of both symptoms was maintained throughout treatment1,2

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

As published in the New England Journal of Medicine,

VIBERZI WAS EVALUATED IN OVER 2400 DIAGNOSED IBS-D PATIENTS

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

* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Discomfort means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is recommended for subject eligibility.
In the absence of use of antidiarrheals or laxatives.
§ Measured over the week prior to randomization.

 

VIBERZI was studied in a wide range of IBS-D patient types

RELIEF STUDY: VIBERZI IN PATIENTS WHO REPORT INADEQUATE CONTROL OF IBS-D SYMPTOMS WITH LOPERAMIDE4

In the Phase 4 RELIEF study, VIBERZI provided significant relief of abdominal pain and diarrhea in patients who reported inadequate control with loperamide4

A significantly greater percentage of patients receiving VIBERZI 100 mg, who reported inadequate control with loperamide, had simultaneous improvement in both abdominal pain and diarrhea compared with placebo4

Data from a randomized, double-blind, placebo-controlled-prospective, multicenter, multinational, Phase 4 clinical trial in IBS-D adult patients aged 18-80. The primary efficacy endpoint was the proportion of primary composite responders in pain and stool consistency determined over the 12-week double-blind treatment period. Primary composite responders were defined as patients who meet the daily response criteria for at least 50% of days with diary entry during the interval of week 1 to 12. Any patient with fewer than 60 days of diary entries was considered a non-responder. Daily composite responders were defined as the following: WAP improvement by ≥40% compared with baseline and BSS <5, OR the absence of BM if accompanied by ≥40% in WAP compared with baseline. Safety assessments included adverse events, clinical laboratory assessments, and vital signs measurements.4

Safety findings from RELIEF were consistent with the findings from the overall Phase 3 patient population and the known safety profile of VIBERZI

BSS = Bristol Stool Score; WAP = Worst Abdominal Pain.
|| P<0.01. Primary Composite=patients who meet daily composite response criteria on ≥50% of days, defined as ≥40% improvement in WAP compared with BL and BSS <5 OR the absence of a BM if accompanied by ≥40% improvement in WAP.
P<0.05. Secondary Stool Consistency = BSS lgt;5 on ≥50% of days.
# P<0.05. Secondary: Worst Abdominal Pain = ≥40% improvement in WAP compared to BL, on ≥50% of days

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NEXT: PATIENT IDENTIFICATION  

Contraindications

VIBERZI is contraindicated in patients:

Warnings and Precautions
Pancreatitis:
Sphincter of Oddi Spasm:
Hypersensitivity Reactions:
Constipation:
Adverse Reactions

The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.

Indications and Usage

VIBERZI (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Please also see full Prescribing Information.

 
IMPORTANT SAFETY INFORMATION
See More
Contraindications

VIBERZI is contraindicated in patients:

  • Without a gallbladder.
  • With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; or structural diseases of the pancreas.
  • With alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day.
  • With a known hypersensitivity reaction to VIBERZI.
  • With severe hepatic impairment.
  • With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Pancreatitis:
  • Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting.
Sphincter of Oddi Spasm:
  • There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking VIBERZI. Serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI.
Hypersensitivity Reactions:
  • In postmarketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration. Some of these reactions occurred after the first one or two doses of VIBERZI.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
Constipation:
  • Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration. In postmarketing experience, severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience severe constipation. Avoid use with other drugs that may cause constipation.
Adverse Reactions

The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.

Indications and Usage

VIBERZI (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Please also see full Prescribing Information.