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Published on 9 October 2008

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Significant success for HE drug

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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

Salix Pharmaceuticals



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