If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ISTM: Rifaximin Effective In Resolving Travelers’ Infectious Diarrhea RALEIGH, NC -- May 30, 2001 -- Salix Pharmaceuticals, Ltd. today announced results from its latest Phase III clinical trial of rifaximin, a minimally absorbed, rifamycin-class antibiotic. The results of this trial, "A Randomized Double-Blind, Parallel, Placebo-Controlled Study of Rifaximin at 600 mg and 1200 mg/day in the Treatment of Bacterial Infectious Diarrhea in Travelers" were presented yesterday at the 7th Conference of the International Society for Travel Medicine in Innsbruck, Austria. The evaluation of the effectiveness of a three-day regimen of rifaximin or placebo was based upon the rapidity of resolution of the diarrhea attack and the modification of stools. The trial's primary efficacy endpoint was Time to Last Unformed Stool (TLUS). The median TLUS, in hours, was: placebo = 60.0, rifaximin 600 mg = 32.5 (p<0.001), and rifaximin 1200 mg = 32.9 (p<0.001.) Secondary efficacy endpoints included the number of unformed stools per 24-hour time interval, rates of wellness and rates of treatment failure. Both rifaximin groups were superior to placebo with respect to the secondary endpoints listed above. Evaluation of safety was based upon the incidence of adverse events (AEs), physical examination, and laboratory investigations. There were no between-group differences in the incidence of the safety measures. This multi-center trial was conducted in 380 subjects affected by acute diarrhea. Study centers were located in Mexico, Guatemala and Kenya. Principal investigators of the study included Herbert DuPont, M.D., Professor of Medicine, University of Texas - Houston; David Sack, M.D., Professor, Department of International Health, for Johns Hopkins University School of Hygiene and Public Health; and Robert Steffen, M.D., Professor, Institute for Social and Preventive Medicine, University of Zurich. Dr. DuPont also serves as a member of the Food and Drug Administration Advisory Committee on Vaccines and Biologics, and he is the author of the guidelines to evaluate new anti-infective therapies for the treatment of acute infectious diarrhea. The findings of this trial, reported yesterday, and the findings of a previously completed head-to-head trial designed to compare the clinical outcomes of rifaximin and ciprofloxacin for the treatment of infectious diarrhea will serve as the basis for Salix's New Drug Application (NDA) for the use of rifaximin in the treatment of infectious diarrhea. In the comparative trial of rifaximin and ciprofloxacin, the primary efficacy endpoint, TLUS, in hours, for rifaximin (median = 25.7) was statistically equivalent to TLUS for ciproflaxacin (median=25.0) (p=0.006). Secondary efficacy endpoints included the number of unformed stools per 24-hour time interval, rates of wellness and rates of treatment failures. There was no statistically significant difference between treatment groups with respect to the secondary endpoints listed above. Evaluation of safety was based upon the incidence of AEs, physical examination, and laboratory investigations. There was no statistically significant difference between treatment groups for any of the safety analyses. This randomized, comparative, double-blind study was conducted in 187 subjects affected by acute diarrhea. Study centers were located in Mexico and Jamaica. "The results of this study are very exciting and, in conjunction with the results of the earlier study, show that rifaximin, if approved by the FDA, could offer an alternative to ciprofloxacin and other fluoroquinolones in the treatment of bacterial infectious diarrhea," said Dr. Herbert DuPont, Professor of Medicine, University of Texas - Houston. "This is an important finding in view of the emergence of fluoroquinolone or quinolone resistance in many parts of the world." "We are keenly interested in the therapeutic potential of this next generation antibiotic," commented Dr. Lorin Johnson, Senior Vice President, Development and Chief Scientific Officer, Salix Pharmaceuticals. "If approved, a safe and effective agent specifically targeted for infections of the gastrointestinal tract would be a very useful addition to the physician's armamentarium. We are encouraged by the results of this latest trial of rifaximin. Based upon the results of our two Phase III trials, we are currently assembling the New Drug Application for the use of rifaximin in the treatment of infectious diarrhea."
SOURCE: Salix Pharmaceuticals, Inc.
|
