Eluxadoline (Viberzi) is a drug designed for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D) in adult men and women. Eluxadoline is in a class of medications called mu-opioid receptor agonists. It works by decreasing bowel activity.
Eluxadoline Approval Recommendation in the EU
July 22, 2016 – The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion for eluxadoline (Truberzi®) in the European Union for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The treatment is approved and licensed in the US under the trade name Viberzi.
Eluxadoline Available in US
December 16, 2015 – Allergan has announced the availability of eluxadoline (Viberzi™) by prescription in the US for the treatment of IBS-D. Eluxadoline is a twice daily, oral medication indicated for use by adults suffering from IBS-D.
May 27, 2015 – The U.S. Food and Drug Administration (FDA) today approved eluxadoline (Viberzi™), a new treatment for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. Viberzi is taken orally twice daily with food. The drug activates receptors in the nervous system that can lessen bowel contractions.
Viberzi is a novel drug compound to treat diarrhea and abdominal pain associated with IBS-D. The safety and effectiveness of the drug for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive the eluxadoline or placebo. Results showed Viberzi was more effective than placebo in simultaneously reducing abdominal pain and improving stool consistency over 26 weeks of treatment.
In clinical trials the drug was generally well tolerated. The most common side effects in patients treated with Viberzi were constipation and nausea.
The most serious known risk associated with Viberzi is the risk of spasm in the sphincter of Oddi, the smooth muscle that surrounds the end portion of the common bile and pancreatic ducts, which can result in pancreatitis. In clinical trials, sphincter of Oddi spasm occurred in less than 1% of the patients receiving Viberzi, which usually arose within the first week of treatment and resolved when they stopped taking Viberzi.
Viberzi should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages per day.
Viberzi has mixed opioid receptor activity. It is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
The FDA recommended that Viberzi be classified as a controlled substance and it was subsequently classified as a Schedule IV controlled substance (low potential for abuse and low risk of dependence). Product availability is expected in early 2016.
Eluxadoline for Treatment of IBS-D in Men and Women Granted Priority Review Status by FDA
In September 2014, the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for eluxadoline for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D) in men and women.
The compound was granted fast-track status by the FDA in acknowledgement of the potential to address a significant unmet medical need for patients with IBS-D. The clinical studies were sponsored by Furiex Pharmaceuticals, which is now a subsidiary of Allergan.