RALEIGH, NC, September 2, 2003 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today announced results of its most recently-completed Phase III Rifaximin clinical study. Results of the study demonstrated that treatment with Rifaximin provided a statistically significant reduction (p
Commenting on the study results, Dr. Art Kamm, Senior Vice President, Research and Development and Chief Development Officer, stated, “These results provide substantial additional information as requested by the U.S. FDA in its October 25, 2002 approvable letter. Consequently, we believe this information will serve a critical role in providing information the FDA needs in order to complete its review of our NDA for Rifaximin. We are extremely pleased to announce these results and continue to expect to submit an amendment to the NDA in or prior to November 2003.”
The multi-center, double-blind, randomized, placebo and active-controlled study evaluated the efficacy of Rifaximin in treating travelers’ diarrhea in 399 adult subjects. The study was conducted at sites located in Mexico, Guatemala, India and Peru.
Source: Salix Pharmaceuticals, Ltd.