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.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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