FDA Approves IBS Drugs by Actavis, Valeant
Actavis has received US Food and Drug Administration (FDA) approval for Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the US 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 the first quarter of 2016.
The specialty pharmaceutical company, Valeant Pharmaceuticals International, also received FDA approval for its IBS-D drug, Xifaxan (rifaximin).. Valeant gained the drugs through its April 2015 acquisition of the specialty pharmaceutical company, Salix Pharmaceuticals.