Posted from: Thursday, July 02, 2015 - 10:43 AM - Present

Viberzi Approved for IBS-D

May 27, 2015 – The U.S. Food and Drug Administration (FDA) approved Viberzi™ (eluxadoline), manufactured by Actavis/Patheon, to treat adults with irritable bowel syndrome with diarrhea (IBS-D). Irritable bowel syndrome which is characterized mainly by loose or watery stools at least 25 percent of the time is estimated to affect about 10 to 15 percent of adults in the United States.

Viberzi is an opioid mu and kappa receptor agonist and delta receptor antagonist, interacts with the opioid receptors in the gut, lessening bowel contractions. The recommended dose is 100mg taken twice daily with food. A lower dose of 75mg twice daily is recommended for patients who do not have a gallbladder, are unable to tolerate the 100mg dose, are receiving concomitant OATP1B1 inhibitors (e.g., cyclosporine, gemfibrozil, certain antiretrovirals, rifampin and eltrombopag), or have mild to moderate hepatic impairment. Patients who develop severe constipation for more than four days should also discontinue Viberzi.

FDA has recommended that Viberzi be classified as a controlled substance and the Drug Enforcement Agency (DEA) is expected classify the medication later this year. Actavis plans on making Viberzi available during the first quarter of 2016 as 75mg and 100mg tablets. 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Wednesday, October 23, 2019 - 05:44 AM.