Actavis: FDA Okays Viberzi To Treat Irritable Bowel Syndrome With Diarrhea

(RTTNews) - Actavis plc (ACT) on Wednesday said the U.S. Food and Drug Administration has approved Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D).

IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men.

The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration. Once Viberzi receives final scheduling designation, the updated label will be available. Pending final scheduling designation, product launch is anticipated in Q1 2016.