FDA approves Viberzi (eluxadoline)for treatment of irritable bowel syndrome with diarrhoea - Actavis

Actavis plc announced that Viberzi (eluxadoline) was approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

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. There are few treatment options available for IBS-D. The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA). Once Viberzi receives final scheduling designation, the updated label will be available. Pending final scheduling designation, product launch is anticipated in Q1 2016.

Comment: The FDA approved Viberzi from Actavis and Xifaxan (rifaximin) from Salix Pharma on the same day for treatment of Irritable Bowel Syndrome with diarrhoea (IBS-D) .Viberzi is taken orally twice a day with food and Xifaxan can be taken orally three times a day for 14 days followed by a further 14 days treatment if there is a recurrence, up to two times.