Salix reports strong Ph III data for rifaximin in HE

The USA's Salix Pharmaceuticals presented strong data from multiple analyses of its Phase III pivotal trial evaluating the efficacy,  safety and tolerability of rifaximin in adult hepatic encephalopathy.  If approved, the late-stage gut-selective antibiotic could become the  first new drug for HE in almost 30 years.

Presented at the annual meeting of the European Association for the  Study of the Liver in Copenhagen, Denmark, these new data, from a large,  randomized, placebo-controlled study of 299 patients, showed that  those who received rifaximin (1,100mg/day, dosed at 550mg twice daily)  for six months had highly statistically-significant protection against  clinical HE breakthrough episodes (58% risk reduction, p<0.0001) in the  intent to treat population.

The analyses also showed that reduction of the risk of HE breakthrough  was maintained across all subgroups in the study, indicating a high  degree of consistency of the ITT outcome. Additionally, the data also  indicated that rifaximin taken 550mg twice daily had a safety profile  comparable to placebo in patients treated for up to six months.