Salix Pharmaceuticals Ltd announced that the US Food and Drug Administration (FDA) has granted marketing approval for Xifaxan (rifaximin) tablets 200 mg for the treatment of travelers' diarrhoea caused by noninvasive strains of E coli in patients 12 years of age and older. Xifaxan is a nonsystemic (less than 0.4 per cent of the drug absorbed into the bloodstream), gastrointestinal-selective, oral antibiotic.
"We are pleased to announce the approval of Xifaxan," stated Carolyn Logan, president and chief executive officer. "We have been working diligently in preparation for this event and look forward to the launch of Xifaxan with great anticipation. We are positioned to leverage our established presence in the marketplace as our 100-member sales and marketing team launches Xifaxan. Clearly, Xifaxan's approval should serve as a key driver toward Salix's goal of profitability for 2004."
Commenting on Xifaxan, Dr. Art Kamm, senior vice president, research and development and chief development officer, stated, " Xifaxan represents a significant new addition to anti-microbial therapy for the treatment of travelers' diarrhoea. In clinical trials, Xifaxan was shown to be effective in shortening the duration of diarrhoea for the most common cause of this disease, noninvasive strains of E coli. Unlike systemically absorbed anti-infective agents, Xifaxan's beneficial effect was achieved with minimal systemic absorption thus reducing the potential for development of systemic antimicrobial resistance and other systemic concerns such as drug-drug interactions.