NOVEMBER 19, 2018

FDA Approves Aemcolo, First Antibiotic for Travelers’ Diarrhea Approved in Over a Decade

By IDSE News Staff

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