FDA Approves New Drug for Travelers’ Diarrhea
The US Food and Drug Administration (FDA) has approved the antibacterial drug rifamycin (Aemcolo), which can treat adults with travelers’ diarrhea caused by noninvasive strains of Escherichia coli, not complicated by fever or blood in the stool.
The approval comes after rifamycin was tested for both efficacy and safety.
Its efficacy was tested through a randomized, placebo-controlled clinical trial in 264 adults with travelers’ diarrhea in Guatemala and Mexico. This study showed that rifamycin significantly reduced symptoms of travelers’ diarrhea compared with placebo.
The drug, which received a Qualified Infectious Disease Product designation from the FDA, was ineffective in participants with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E coli.
The safety of rifamycin, taken orally over 3 or 4 days, was evaluated in 619 adults with travelers’ diarrhea in 2 controlled clinical trials. The most common adverse reactions with rifamycin were headache and constipation.
“Aemcolo should not be used in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components in Aemcolo,” the FDA wrote in a statement.
FDA approves new drug to treat travelers’ diarrhea [press release]. Silver Spring, MD: US Food and Drug Administration; November 16, 2018. Accessed November 19, 2018.