Salix Pharmaceuticals Ltd have announced FDA approval for Xifaxan.
Xifanax (rifaximin) is a nonsystemic, gastrointestinal-selective, oral antibiotic. It is expected to be available to physicians and patients in August.
Xifanax tablets are indicated for the treatment of patients (12 years of age and older) with travelers' diarrhea caused by noninvasive strains of Escherichia coli.
In clinical trials, Xifanax was generally well tolerated. The most common side effects were flatulence, headache, abdominal pain and rectal tenesmus.
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' diarrhea“.
“In clinical trials, Xifaxan was shown to be effective in shortening the duration of diarrhea 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“.