Salix reports positive findings in six trials of Xifaxan

New York, Oct. 31 - Salix Pharmaceuticals, Ltd. reported positive findings from six trials of Xifaxan (refaximin) presented at the American College of Gastroenterology 2005 Annual Scientific Meeting in Honolulu.

"The presentations this week at [the American College of Gastroenterology] are an indication of researchers' and clinicians' interest in and the potential of Xifaxan, a nonsystemic, gastrointestinal-selective, oral antibiotic to potentially address the bacterial component of a wide variety of gastrointestinal medical needs - including irritable bowel syndrome, hepatic encephalopathy and inflammatory bowel disease," said Bill Forbes, vice president, research and development, and chief development officer, at Salix, in a news release.

"The findings of these exploratory trials add to our expanding body of knowledge that we are utilizing to prioritize and design programs to develop Xifaxan as a therapeutic option in a number of GI diseases. We intend to initiate trials in a number of these areas in the coming months."

A study by Mark Pimentel of Cedars-Sinai Medical Center, Los Angeles, found revealed a statistically significant improvement in subjects receiving Xifaxan versus placebo-treated subjects with irritable bowel syndrome. Of those receiving the drug, 38% reported an improvement versus 23% for the placebo.

Bloating was improved in those that received Xifaxan.

For hepatic encephalopathy, the number of hospitalizations was significantly reduced in patients during their treatment with Xifaxan versus their time on lactulose therapy at 0.5 compared to 1.6, according to a study by Carroll Leevy, associate professor of medicine and associate director for clinical affairs at The New Jersey Medical School Liver Center and Sammy Davis, Jr. National Liver Institute, Newark.

In mild to moderately active Crohn's disease, Leonard Baidoo, of Graduate Hospital, Philadelphia, found 75% of patients responded to treatment with Xifaxan of which 67% reported complete remission and 33% reported a greater than 50% response.

Looking at Crohn's disease, Wojciech Blonski of the University of Pennsylvania School of Medicine, Philadelphia, reported that a patient with known colonic Crohn's disease for 15 years and a history of three Crohn's disease flares that had been treated with corticosteroids was treated with Xifaxan 800 mg daily (400 mg BID) for two weeks. The therapy resulted in discontinuance of steroids and resolution of symptoms.

Daniel Feldman of the division of gastroenterology, Maimonides Medical Center, Mount Sinai School of Medicine, Brooklyn, N.Y., conducted a study to assess the efficacy and tolerability of Xifaxan 800 mg daily (400 mg BID) in 27 inflammatory bowel disease patients. Thirteen of 14 predinsone patients responded to therapy while 11 of 13 Xifaxan patients responded to therapy.

For H. pylori gastritis, Raouf Hilal of the Center for Advanced Gastroenterology, Maitland, Fla., investigated the efficacy and tolerability of Xifaxan, doxycycline and lansoprazole. The treatment successfully eradicated H. pylori gastritis in seven (30.4%) of the 23 patients who completed the four-week study. Side effects were minimal.

Salix is a Raleigh, N.C., pharmaceutical company focused on gastrointestinal diseases.

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