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news.Salix Pharmaceuticals, a provider of prescription pharmaceutical products, has announced the successful completion and outcome of its pivotal Phase III trial to evaluate the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy.
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This study demonstrates that the protocol-specified, intent-to-treat, primary endpoint comparison of a six-month course of rifaximin at 550mg dosed twice-a-day provides a highly statistically significant result in preventing hepatic encephalopathy, compared to placebo. The results seen with the primary endpoint are corroborated by the secondary endpoints.
Bill Forbes, chief development officer of Salix, said: “We are extremely pleased with the outcome of our 299-patient, multicenter, randomized, double-blind, placebo-controlled trial of rifaximin. The results of this trial, which to our knowledge is the largest hepatic encephalopathy trial ever conducted, support earlier work that suggests rifaximin may be a suitable and well-tolerated agent for hepatic encephalopathy.
“We intend to meet with the FDA in the near future to discuss the results of this trial and appropriate next steps for submitting a new drug application to the FDA. Based on the results of this trial, we are excited about the prospects for rifaximin.”