Salix Releases Results From Phase-III Rifaximin Study

CHICAGO AND RALEIGH—Salix Pharmaceuticals, Ltd. today announced the presentation of new data from its Phase III pivotal clinical trial evaluating the efficacy, safety and tolerability of rifaximin—a non-absorbed (<0.4 percent), gut selective antibiotic—in adult patients with hepatic encephalopathy (HE).

These data, presented during two oral sessions at the annual meeting of Digestive Disease Week (DDW) being held this week in Chicago (May 30-June 4, 2009), demonstrated that rifaximin significantly reduced the risk of HE-related hospitalizations in patients with previous episodes of HE and showed a highly significant reduction in the risk of breakthrough HE during the six month study. 

The new data come from two additional analyses of the pivotal Phase III, multinational, randomized, double-blind, placebo-controlled study of 299 patients with a history of HE.  The data showed that patients who received rifaximin (1100 mg/day, dosed at 550 mg twice daily) for six months experienced a highly statistically significant reduction in the risk of breakthrough HE compared to those who received placebo (58 percent risk reduction, p<0.0001) in the intent to treat (ITT) population.