FDA committee recommends approval of Xifaxan

RALEIGH, N.C. A Food and Drug Administration committee has recommended approval for a drug to treat a brain disease that results from liver malfunction.

Salix Pharmaceuticals said this week that the FDA’s Gastrointestinal Drugs Advisory Committee had recommended approval of the drug Xifaxan (rifaximin) tablets in the 550-mg strength for maintenance of remission of hepatic encephalopathy. The FDA’s recommendation was based on a review of a 299-patient phase-3 clinical trial of the drug.

The disease often occurs in patients with cirrhosis as a result of end-stage liver disease. Cirrhosis results from such factors as viral hepatitis, autoimmune disease and long-term abuse of drugs and alcohol, affecting more than 600,000 people in the United States.

“We are very pleased with the advisory committee’s support for the approval of Xifaxan 550-mg tablets,” Salix SVP research and development and chief development officer Bill Forbes said. “If approved, Xifaxan 550-mg will be the first new option for the management of hepatic encephalopathy in over 30 years.”