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A phase III trial looking at the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy (HE) has shown “significant” success in preventing the condition.
There are currently no FDA-approved drug therapies available for HE, which encompasses a spectrum of reversible neuropsychiatric abnormalities that occur in patients with acute or chronic liver disease.
The US trial, in which almost 300 patients were given a six-month course of rifaximin in twice-daily doses of 550mg, was shown to prevent HE in a “highly statistically significant” number of cases.
Bill Forbes, lead researcher at Salix Pharmaceuticals, which developed the drug, said: “We are extremely pleased with the outcome of our 299-patient, multi-centre, randomised, 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 US Food and Drug Administration. Based on the results of this trial, we are excited about the prospects for rifaximin.”
Copyright PA Business 2008
