FDA Advisory Committee recommends approval of Xifaxan (rifaximin) tablets, 550 mg for maintenance of remission of hepatic encephalopathy.

Salix Pharmaceuticals Ltd (Salix) has reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended in favour of the approval of Xifaxan (rifaximin) tablets, 550 mg for the maintenance of remission of hepatic encephalopathy. If approved, Xifaxan 550 mg will be the first new option for the management of hepatic encephalopathy. Salix believes the availability of Xifaxan 550 mg has the potential to change the treatment paradigm for hepatic encephalopathy. The committee reviewed data from the company's 299-subject, double-blind, placebo-controlled, multinational, Phase III study. This study demonstrated a statistically significant and clinically meaningful reduction …