Viberzi eluxadoline regulatory update

FDA approved an NDA for Viberzi eluxadoline from Actavis to treat irritable bowel syndrome with diarrhea (IBS-D). Actavis said the agency recommended the locally acting mu opioid receptor (MOR; OPRM1) agonist and delta opioid receptor antagonist be classified as a controlled substance and submitted the recommendation to the U.S. Drug Enforcement Agency (DEA). Pending the final scheduling designation, Actavis expects Viberzi will be launched in 1Q16. ...