Xifaxan 550mg approved to reduce risk of hepatic encephalopathy

The FDA has approved Xifaxan (rifaximin tablets, from Salix Pharmaceuticals) 550mg for the reduction in risk of recurrence of overt hepatic encephalopathy in patients ≥18 years of age with advanced liver disease. This approval is based on data from a Phase 3, randomized, double-blind, placebo-controlled, multinational trial of patients with liver disease who had no or mild symptoms of hepatic encephalopathy. The primary endpoint, the risk of experiencing a breakthrough overt hepatic encephalopathy episode, was reduced by 58% in patients treated with Xifaxan 550mg compared with placebo (p<0.0001). The key secondary endpoint, risk of experiencing hepatic encephalopathy-related hospitalization, was reduced by 50% in patients treated with Xifaxan 550mg compared with placebo (p=0.0129).

Xifaxan 550mg is expected to be available by the end of May 2010. Xifaxan is already available in a 200mg dosage strength tablet indicated for the treatment of traveler’s diarrhea due to noninvasive Escherichia coli.

For more information call (800) 508-0024 or visit www.salix.com.