Salix says phase 3 trial shows Xifaxan successfully prevents travelers from getting diarrhea

By E. Janene Geiss

Philadelphia, Jan. 4 - Salix Pharmaceuticals, Ltd. announced the successful completion and outcome of its first phase 3 study to evaluate the efficacy and safety of Xifaxan (rifaximin) tablets 200 mg for the prevention of travelers' diarrhea.

In a 210-subject, phase 3 trial designed to evaluate the efficacy and safety of 600 mg Xifaxan, 84% of Xifaxan-treated travelers remained free from diarrhea versus 50% of placebo-treated travelers. This result was found to be highly statistically significant, according to a company news release.

The trial enrolled travelers to Mexico with 106 receiving Xifaxan and 104 receiving placebo.

The primary endpoint was defined as the relative risk of diarrhea during the 14-day treatment period for the drug compared to placebo based upon time to first unformed stool associated with travelers' diarrhea.

"The results of this trial are a very important step forward in our pursuit of a prevention of travelers' diarrhea indication for Xifaxan," Bill Forbes, vice president, research and development and chief development officer of Salix, said in the release.

The company said it plans to begin a second trial during the first quarter of this year.

Xifaxan, a gut selective, non-systemic, virtually non-absorbed oral antibiotic, is approved for the treatment of travelers' diarrhea caused by noninvasive strains of E. coli in patients 12 years of age and older.

Data from previous studies carried out in Mexico, Guatemala, Jamaica, India and Kenya have found Xifaxan to be effective as a treatment for travelers' diarrhea.

A review of travelers' diarrhea in the June 2005 issue of The Lancet suggests that Xifaxan as a preventative agent may represent a viable alternative to currently available systemic antibiotics, officials said.

In May 2005, the Annals of Internal Medicine reported results of an investigator-initiated trial in which Dr. Herbert DuPont of the University of Texas-Houston Baylor School of Medicine evaluated Xifaxan in preventing travelers' diarrhea.

The company-sponsored, phase 3 trial reported Wednesday was conducted to replicate and confirm the results of the investigator-initiated trial, officials said.

Travelers' diarrhea affects about 20 million people annually, putting them in bed for a day or more while decreasing their energy for considerably longer, officials said.

Salix, based in Raleigh, N.C., develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

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