Viberzi

Viberzi is a drug prescribed to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. The drug’s main ingredient is eluxadoline. Allergan got approval to sell the medication in the United States in 2015. In 2017, the U.S. Food and Drug Administration warned that the drug could cause pancreatitis in people who do not have a gallbladder.

Viberzi Tablet 100 mg
Viberzi Facts
  1. MANUFACTURER Allergan
  2. ACTIVE INGREDIENT Eluxadoline
  3. USED TO TREAT Irritable bowel syndrome with diarrhea (IBS-D) in adults

Viberzi (eluxadoline) is a prescription drug marketed by Allergan for the treatment of irritable bowel syndrome with diarrhea (IBS-D). It belongs to a class of drugs known as mu-opioid receptor agonists.

The U.S. Food and Drug Administration originally approved the drug in 2015. Viberzi is the first and only prescription therapy in its drug class to treat IBS-D, according to Allergan’s Viberzi website.

About 10 percent to 15 percent of the world’s population suffers from IBS, which is a chronic disease that causes abdominal pain or discomfort along with changes in defecation and bowel habits. In the United States, 25 million to 45 million people have IBS. IBS-D is a subtype of IBS that causes frequent diarrhea. Worldwide, about 40 percent of people with IBS have IBS-D.

DID YOU KNOW?
Eluxadoline is a controlled Schedule IV substance.
Source: U.S. Department of Justice and Drug Enforcement Administration

Eluxadoline is a controlled Schedule IV substance, according to the U.S. Department of Justice and Drug Enforcement Administration. Some studies detailed in the drug’s label showed Viberzi has the potential for psychological dependence because it can produce feelings of euphoria in humans.

In 2018, the drug made $176.5 million for Allergan in the United States, according to the company’s 2018 Securities and Exchange Commission report.

The most common side effects of Viberzi include constipation, nausea and abdominal pain. The most common reasons patients stopped taking the drug during clinical trials were constipation and abdominal pain. Serious side effects include pancreatitis and sphincter of Oddi spasms.

In 2017, the FDA released a drug safety communication that warned about an increased risk of pancreatitis in patients who do not have a gallbladder. This led some patients to file Viberzi lawsuits against Allergan.

How Does Eluxadoline Work?

In people with IBS-D, the intestines contract more than they should, especially after meals. This causes discomfort and diarrhea.

Viberzi works to control IBS-D symptoms by:
  • Reducing nerve sensitivity in the intestine
  • Slowing movement of food through the colon

In animals studies, Viberzi worked by affecting three different kinds of opioid cell receptors in the body: mu, delta and kappa. These receptors work in the gut and affect muscle movements, sensations and secretions.

Scientists call it a mixed-opioid medication because it affects three receptors. Because of how it works, the medicine is less likely to cause constipation. It also works directly on receptors in the intestines, so it is less likely to cause additional central nervous system side effects.

Recommended Dosages

Viberzi is available in 75 mg and 100 mg tablets. The typical recommended dosage is 100 mg taken twice daily by mouth with food.

Doctors may recommend certain patients take 75 mg twice daily. These patients include those who:
  • Cannot tolerate 100 mg dose
  • Are also taking OATP1B1 inhibitors
  • Have mild or moderate liver impairment

Two doses should not be taken at the same time to make up for a missed dose. A doctor may recommend a patient stop treatment if he or she experiences side effects, such as severe constipation.

Drug Effectiveness and Interactions

Allergan tested Viberzi’s effectiveness in two clinical trial studies with 2,426 participants. The average patient age was 45 years old.

A majority of the participants were white and two-thirds were female. IBS is more common in females.

In these studies, scientists measured average worst abdominal pain and stool consistency in people taking eluxadoline and placebo.

“In both trials, the proportion of patients who were composite responders to Viberzi was statistically significantly higher than placebo for both doses,” according to the drug’s label.

Compared with alosetron, another drug approved for IBS, eluxadoline has a lower potential for side effects and drug interactions, according to an article by pharmacists Fraidy Maltz and Brooke Fidler in Pharmacy and Therapeutics. But it has a similar side effect profile as the IBS-D drug rifaximin.

Potential for Abuse and Dependence

As a Schedule IV controlled substance, Viberzi has the potential for abuse. Though, the DEA considers the potential low compared to other controlled substances such as ketamine and codeine.

Animal studies in monkeys and rats did not produce behavioral signs of withdrawal, but monkeys wanted to self-administer the drug. In studies on monkeys, the animals chose to self-administer the drug “to a degree that was less than that of heroin but greater than that of saline,” according to the drug’s label.

Very few people reported feeling euphoric or drunk in clinical trials. But in two human abuse potential studies, people who had taken Viberzi experienced euphoria at a rate of 14 percent to 28 percent. By comparison, the rate was less than 5 percent among people who had taken a placebo and between 44 percent and 76 percent among people who had taken oxycodone. Participants in the studies had experienced recreational opioid use.

“These data suggest that eluxadoline may produce psychological dependence,” according to the drug’s label.

Drug Interactions

Drugs that may interact with Viberzi include:
  • OATP1B1 inhibitors, such as cyclosporine, rifampin, gemfibrozil, eltrombopag, and antiretrovirals like ritonavir, saquinavir and tipranavir
  • Strong CYP inhibitors, such as ciprofloxacin, gemfibrozil, fluconazole, paroxetine, bupropion and clarithromycin
  • Drugs that cause constipation, such as alosetron, anticholinergics and opioids
  • CYP3A substrates, such as alfentanil, cyclosporine, ergotamine, fentanyl, quinidine, dihydroergotamine, pimozide, sirolimus and tacrolimus
  • OATP1B1 and BCRP substrate

People Who Should Not Take Viberzi

The FDA approved Viberzi for use only in adults. It’s unknown whether the drug is safe or effective in children. While the drug works for most adults with IBS-D, some patients might react poorly to the medicine.

CONTRAINDICATIONS REASONS
Patients without a gallbladder Increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm
People with known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction Increased risk for sphincter of Oddi spasm
Those who drink more than three alcoholic beverages per day, or suffer from alcoholism, abuse alcohol or alcohol addiction Increased risk for acute pancreatitis
Patients with a history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction Increased risk for acute pancreatitis
People with severe liver problems Risk for significantly increased plasma concentrations of eluxadoline
Those with a history of chronic or severe constipation, or known or suspected gastrointestinal obstruction Risk for severe complications of bowel obstruction
Patients with a known hypersensitivity reaction to the drug Serious hypersensitivity reactions, including anaphylaxis, can occur after the first or second dose
Source: Viberzi’s FDA-approved drug label

Pregnancy and Breastfeeding

No studies have tested Viberzi in pregnant women, so it’s unknown how the drug affects expectant mothers and fetuses.

Eluxadoline was present in rat milk in animal studies. Before taking the drug, patients should tell their doctor if they are breastfeeding.

FDA Safety Alert

On March 15, 2017, the FDA warned in a safety communication that people who do not have a gallbladder should not use Viberzi.

From May 2015 through February 2017, the FDA Adverse Event Reporting System (FAERS) database received 120 reports of serious cases of pancreatitis or death in patients who had taken Viberzi. Patients in 76 of these cases needed hospitalization, and two patients died.

“The case of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi,” the FDA said in its safety communication. “The case of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi.”

Gallbladder Illustration
The U.S. Food and Drug Administration warns patients who do not have a gallbladder not to take Viberzi. The above image is an illustration of a gallbladder.

A total of 68 cases reported gallbladder status. Patients in 56 of the cases did not have a gallbladder and received the recommended dose of Viberzi.

Meanwhile, 84 cases noted when symptoms started. More than half said the serious cases of pancreatitis or death occurred after one or two doses of the drug.

The FDA said it was working with Allergan to address this safety issue.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

8 Cited Research Articles

  1. Allergan. (2018). Form 10-K for The Year Ended December 31, 2018. Retrieved from https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allerganinvestors/financial-information/proxy-materials/2018_10-k.pdf
  2. Allergan. (n.d.). What is IBS-D? Retrieved from https://www.viberzi.com/about-ibsd/what-is-ibsd
  3. Allergan. (n.d.). What is Viberzi? Retrieved from https://www.viberzi.com/about-viberzi/what-is-viberzi
  4. American Pharmacists Association. (2015, July 1). Two new choices with Patients for IBS-D. Retrieved from https://www.pharmacist.com/article/two-new-choices-patients-ibs-d
  5. Maltz, F. & Fidler, B. (2017). Eluxadoline (Viberzi): A Mu-Opioid Receptor Agonist for the Treatment Of Irritable Bowel Syndrome With Diarrhea. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481293/
  6. U.S. Department of Justice/Drug Enforcement Administration. (n.d.). PART 1308 — Schedules Of Controlled Substances. Retrieved from https://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_14.htm
  7. U.S. Food and Drug Administration. (2017, March 15). FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-increased-risk-serious-pancreatitis-irritable-bowel
  8. U.S. Food and Drug Administration. (2018, April). Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s003lbl.pdf
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