Mar. 25, 2010 (United Press International) -- The U.S. Food and Drug Administration says it has approved Xifaxan for reducing the risk of overt hepatic encephalopathy recurrence in advanced liver disease.
The FDA said its approval marks a new use for Xifaxan (rifaximin), a drug that has been previously approved for the treatment of traveler's diarrhea.
Hepatic encephalopathy is a worsening of brain function that can occur in patients whose liver can no longer remove toxins from the blood, officials said. Increased levels of ammonia in the blood are thought to play a role in the development of hepatic encephalopathy, and Xifaxan works by reducing those levels.
"The approval of Xifaxan for this new indication provides an additional treatment option for patients with liver disease," said Dr. Joyce Korvick, deputy director for safety in the FDA's Division of Gastroenterology Products. "Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition."
Xifaxan is manufactured by Salix Pharmaceuticals (NASDAQ:SLXP) Inc. of Morrisville, N.C.
