VIDEO TRANSCRIPT

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GUT RESPONSES logo

HCPs SHARE HOW THEY TREAT IBS-D

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VIBERZI logo

AVO: VIBERZI, also known as eluxadoline, is indicated in adults for the treatment of irritable bowel syndrome with diarrhea. See safety information at the end of this video.

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“I typically use VIBERZI for the more severe patient.” appears.

AVO: “I typically use VIBERZI for the more severe patient.”

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DR. ARIN NEWMAN AND HIS TITLE/LOCATION APPEARS

ARIN H. NEWMAN, MD

Gastroenterologist

MIAMI, FLORIDA

DR. NEWMAN: There are different degrees of IBS-D, from mild to moderate to severe. In my practice the majority of patients are not severe.

Many patients have already tried changes in dietary habits and over-the-counter therapies, and in some cases their symptoms still persist.

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Dr. Newman and study design and disclaimer appears.

VIBERZI Pivotal Trials Study Design

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 StoolScale. 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 Diff13%, 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%).

DR. NEWMAN:VIBERZI is a therapy that targets the two main symptoms of IBS-D: diarrhea and abdominal pain. Adult patients with IBS-D were studied in the Phase 3 trials.

Patients enrolled were included if they had a mean worst abdominal pain score of greater than 3.0 (on a scale of 0 to 10, with 0 indicating no pain. and 10 the worst imaginable pain), and an average stool consistency score of 5.5 or more on the Bristol Stool Form Scale (which ranges from 1 to 7, with 1 indicating hard stool and 7 indicating watery diarrhea).

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Dr. Newman and the following chart appears.

VIBERZI Efficacy

Responders at 3 and 6 months*IBS-3002

% Responders at 3 months

30% VIBERZI 100 mg vs 16% Placebo% Responders at 6 months

33% VIBERZI 100 mg vs 20% Placebo

Responders at 3 and 6 months*

IBS-3001

% Responders at 3 months

25% VIBERZI 100 mg vs 17% Placebo% Responders at 6 months

29% VIBERZI 100 mg vs 19% Placebo

*Statistically significantly higher at Month 3. Numerically greater at Month 6.

DR. NEWMAN: VIBERZI showed statistically significant improvement in those symptoms, and provided lasting relief.

Relief of both symptoms was maintained throughout treatment; 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 6.

DR. NEWMAN: VIBERZI showed statistically significant improvement in those symptoms, and provided lasting relief.

Relief of both symptoms was maintained throughout treatment; the proportion of patients who were combined responders to VIBERZI at each4-week interval was numerically higher than placebo as early as month 1through month 6.

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Dr. Newman and the following chart appears.

VIBERZI Safety Common AEs*

Constipation was common when taking VIBERZI 100 mg BID in 8%[N=1032], vs VIBERZI 75 mg BID in 7% [N=807], vs Placebo in 2%[N=975]

Nausea was common when taking VIBERZI 100 mg BID in 7%[N=1032], vs VIBERZI 75 mg BID in 8% [N=807], vs Placebo in 5%[N=975]

Abdominal Pain† was common when taking VIBERZI 100 mg BID in7% [N=1032], vs VIBERZI 75 mg BID in 6% [N=807], vs Placebo in4% [N=975]

Upper Respiratory Tract Infection was common when taking VIBERZI 100 mg BID in 5% [N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 4% [N=975]

Vomiting was common when taking VIBERZI 100 mg BID in 4%[N=1032], vs VIBERZI 75 mg BID in 4% [N=807], vs Placebo in 1%[N=975]

Nasopharyngitis was common when taking VIBERZI 100 mg BID in 3% [N=1032], vs VIBERZI 75 mg BID in 4% [N=807], vs Placebo in 3% [N=975]

Nasopharyngitis was common when taking VIBERZI 100 mg BID in3% [N=1032], vs VIBERZI 75 mg BID in 4% [N=807], vs Placebo in3% [N=975]

Abdominal Distention was common when taking VIBERZI 100 mg BID in 3% [N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2% [N=975]

Abdominal Distention was common when taking VIBERZI 100 mgBID in 3% [N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2% [N=975]

Bronchitis was common when taking VIBERZI 100 mg BID in 3%[N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2%[N=975]

Dizziness was common when taking VIBERZI 100 mg BID in 3%[N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2%[N=975]

Flatulence was common when taking VIBERZI 100 mg BID in 3%[N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2%[N=975]

Rash‡ was common when taking VIBERZI 100 mg BID in 3%[N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2%[N=975]

Increased ALT was common when taking VIBERZI 100 mg BID in 3% [N=1032], vs VIBERZI 75 mg BID in 2% [N=807], vs Placebo in1% [N=975]

Increased ALT was common when taking VIBERZI 100 mg BID in3% [N=1032], vs VIBERZI 75 mg BID in 2% [N=807], vs Placebo in1% [N=975]

Fatigue was common when taking VIBERZI 100 mg BID in 2%[N=1032], vs VIBERZI 75 mg BID in 3% [N=807], vs Placebo in 2%[N=975]

Viral Gastroenteritis was common when taking VIBERZI 100 mgBID in 1% [N=1032], vs VIBERZI 75 mg BID in 2% [N=807], vs Placebo in 2% [N=975]

*Adverse events (AEs) were reported in >2% of patients treated with VIBERZI at either dose and at an incidence greater than in patients treated with placebo.

^†Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain.

^‡Rash includes: dermatitis, dermatitis allergic, rash, erythematous rash, generalized rash, maculopapular rash, popular rash, pruritic rash, urticaria, and idiopathic urticaria.

DR. NEWMAN: So VIBERZI has been proven to be safe and effective across a range of IBS-D severity.

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Dr. Newman and study design and disclaimer appears.

VIBERZI RELIEF Study Design

Data from a double-blinded, randomized, placebo-controlled, prospective, multicenter, multinational phase 4 study of IBS-D in adult patients aged 18 to 80 years with an intact gall bladder (N=346). Patients in the RELIEF trial were excluded if they had a cholecystectomy.

In the RELIEF trial, a responder was defined as a patient with ≥40% reduction in daily abdominal pain and improvement in daily stool consistency to <5 on the Bristol StoolScale on at least 50% of days in the trial.

Those who reported improvement in abdominal pain in the absence of a bowel movement were also considered responders.

DR. NEWMAN: Now as I’ve mentioned, many patients will have already taken loperamide even before they come to see you.

The VIBERZI Relief trial studied patients who had taken loperamide and reported inadequate symptom control.

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Dr. Newman and the following charts appear

Percentage of Composite Responders over 3 months

RELIEF Study

VIBERZI 100 mg 22.7% vs Placebo 10.3% (Treatment Difference: 12/4%; P=0.002).

Treatment Emergent AEs ≥2 in any group

Nausea was common when taking VIBERZI 100 mg BID in 6% [N=171], vs Placebo in 3% [N=173]

Constipation was common when taking VIBERZI 100 mg BID in 5% [N=171], vs Placebo in 1% [N=173]

Nasopharyngitis was common when taking VIBERZI 100 mg BID in 4% [N=171], vs Placebo in 2% [N=173]

Influenza was common when taking VIBERZI 100 mg BID in 3% [N=171], vs Placebo in 2% [N=173]

Sinusitis was common when taking VIBERZI 100 mg BID in 3% [N=171], vs Placebo in 1% [N=173]

Headache was common when taking VIBERZI 100 mg BID in 3% [N=171], vs Placebo in 1% [N=173]

Upper Respiratory Tract Infection was common when taking VIBERZI 100 mg BID in 3% [N=171], vs Placebo in 0% [N=173]

Abdominal Pain was common when taking VIBERZI 100 mg BID in 2% [N=171], vs Placebo in 2% [N=173]

Vomiting was common when taking VIBERZI 100 mg BID in 2% [N=171], vs Placebo in 1% [N=173]

Blood Creatinine Increased was common when taking VIBERZI 100 mg BID in 2% [N=171], vs Placebo in 1% [N=173]

DR. NEWMAN: Please see the results of the RELIEF trial on the screen at this time.

What do these results mean to you?

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Dr. Newman

DR. NEWMAN: There are certain populations where additional discussion should take place prior to starting therapy. But, in appropriate adult patients, across a range of IBS-D severity, VIBERZI may be an effective therapy. Thank you.

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Indication, Usage and Important Safety Information appears.

AVO

INDICATIONS AND USAGE

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

IMPORTANT SAFETY INFORMATION

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 post marketing 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 post marketing 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.

Please see full Prescribing Information or visit https://www.rxabbvie.com/pdf/viberzi_pi.pdf.