The FDA approved rifamycin (Aemcolo, Cosmo Pharmaceuticals) for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli, not complicated by fever or blood in the stool.
Rifamycin was approved based on data from two randomized controlled, multicenter, phase 3 clinical trials. In both trials, rifamycin was dosed at 388 mg twice daily for three days. Rifamycin demonstrated superiority to placebo (P=0.0008) and noninferiority to