XIFAXAN® 550mg (rifaximin-α) Registered for Reduction of Recurrence of Episodes of Overt Hepatic Encephalopathy in the EU*

XIFAXAN® 550mg (rifaximin-α) Registered for Reduction of Recurrence of Episodes of Overt Hepatic Encephalopathy in the EU* PR Newswire BOLOGNA, Italy and AMSTERDAM, December 7, 2012 BOLOGNA, Italy and AMSTERDAM, December 7, 2012 /PRNewswire/ -- Alfa Wassermann and Norgine are pleased to announce that they have received European Marketing Authorisation for ® ® ® ®XIFAXAN 550mg (rifaximin-α) / REFERO / TARGAXAN / TIXTELLER in the reduction of recurrence of episodes of overt hepatic encephalopathy (HE) in patients ≥ 18 years of age, in a number of EU territories*. HE is a potentially [1] life-threatening neuropsychiatric condition associated with liver cirrhosis . First launches in Europe are expected in the first half of 2013. Rifaximin-α, developed by Alfa Wassermann, is currently marketed in many countries worldwide, including the US in a number of indications. [2] ®A pivotal trial by Bass and colleagues (2010) demonstrated the efficacy of twice-daily (bid) treatment with XIFAXAN 550mg in patients with HE. Hepatic encephalopathy results from increased serum toxic substances such as ammonia arising from gut bacteria, [1]which is not efficiently removed by the damaged liver and then enters the brain causing a spectrum of neuropsychiatric disorders ranging from mild intellectual impairment, changes in mental state, confusion, to personality [3]changes, depressed level of consciousness and even coma .