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.

FDA Approves Eluxadoline (Viberzi™) for Treatment of IBS-D in Men and Women

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.

Industry Treatment News
Eluxadoline (Viberzi)
Eosinophilic Esophagitis Study
Linaclotide (Linzess)
Linaclotide Study for IBS in Children
Linaclotide Study for FC in Children
Medical News
Medical News - Archive
Special Events & Meetings
Press Releases
2016-0801 Learn the Facts About Gastroparesis
2016-0405 Think You Have IBS? Find Out For Sure Before Starting a Treatment
2015-1123 Is it More than Simple Heartburn? Ask Your Doctor.
2015-7-30 Gastroparesis is a Hidden Medical Condition for Many
2015-0330 Online Survey Looks to Help Improve Outcomes for those with IBS
2014-1119 Persistent Heartburn May Be a Sign of GERD
2014-0826 Lack of Awareness of Gastroparesis May Impact Medical Care
2014-0326 IFFGD Marks IBS Awareness Month with Launch of Mobile App
2014-0225 IFFGD Research Grants to Study Gastroparesis
2013-1106 15 Tips for GERD Awareness Week
2013-0626 New DHA.org
2013-0412 IFFGD Presents 2013 Research Awards
2013-0401 Turning Attention to Returning Vets
2012-1109 Banish Frequent Heartburn by Burning More Calories
2012-0321 April is IBS Awareness Month: A Serious Issue for Veterans
2006-0418 Natl Commission
2001-1119 Heartburn or Heart Attack
2006-0321 Women's Health
2011-1130 Is Your Child's Reflux/Spitting Up A Point of Concern?
2006-0202 IBS or Something Else
2011-0412 IFFGD Research Award Winners
2005-1125 GERD Costs
2005-0412 IBS Awareness
2011-0329 IBS Signs You Should Not Ignore
2010-1118 GERD Difference
2004-1125 Heartburn & Heartache
2004-0929 Norton Honored
2009-1109 GERD at Night
2010-0517 US House Resolution for IBS
2010-1001 Heartburn or GERD?
2006-1116 GERD & Holidays
2007-0401 IBS Myths
2009-0417 IFFGD Research Award Recipients
2004-0525 IBS Travel Tips
2007-1118 When Is Simple Heartburn Not So Simple?
2008-0331 Dealing with Digestive Disorders
2004-0101 IFFGD Conference
2004-0408 IBS Medical Care
2007-0718 Proposed FDA Funding Applauded
2003-1117 GERD Treatment
2003-0401 IFFGD Research Awards
2003-0401 IBS Awareness
2002-1102 Heartburn Caution
2002-0423 IBS in Real World
2002-0423 IBS-C Treatment
2002-0402 IBS & Lost Potential
2001-0322 Patients First
1998-0401 IBS Millions Suffer
1997-1114 Research & Women's Health
Misunderstood Functional GI Disorders
IBS is No Joking Matter
For Media
Reporters' Guides
Media Contact Form

Join the conversation

join conversation

Keep up-to-date on the latest news, stories, tips, research highlights, and more!

Sign up for eNewsletter

Connect through Facebook

Follow us on twitter