Following recent European Union approval (The Pharma Letter December 9, 2012), Netherlands-based Norgine Pharmaceuticals and Italy’s Alfa Wassermann have announced the first European launch of Targaxan (rifaximin-alpha, also trade-named Refero, Xifaxan and Ticteller) in the UK.
In the UK, it is the only treatment available that is licensed for the reduction in recurrence of episodes of overt hepatic encephalopathy (HE) in patients ≥ 18 years of age, a potentially life-threatening neuropsychiatric condition associated with liver disease. Rifaximin-alpha, developed by Alfa Wassermann, is currently marketed in many countries worldwide, including the USA in a number of indications.
The pivotal clinical trial by Bass et al (2010), in which patients in remission from recurrent episodes of hepatic encephalopathy due to cirrhosis who were treated with Targaxan 550mg twice-daily (bd) with or without lactulose, were compared with patients given placebo (bd) with or without lactulose over six months, demonstrated:
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