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.