Aemcolo Approved to Treat Travelers
November 19, 2018 – The U.S. FDA has approved Aemcolo™ (rifamycin), manufactured by Aries Pharmaceuticals, to treat adults who have travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli). Aemcolo is the first new antibiotic approved to treat travelers’ diarrhea in over ten years.
An estimated 10-40% of travelers experience travelers’ diarrhea worldwide each year. The condition is the most common form of travel-related illness, and can be caused by a number of different organisms. Typically, it occurs following exposure to bacteria in food and water.
In clinical trials, Aemcolo delivered a significant reduction in symptoms compared to placebo. However, it did not demonstrate efficacy in cases where the patient had complications of fever or blood in the stool. Recommended dosing is two 194mg tablets, taken with a glass of liquid, twice daily for three days.
Aemcolo is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®), which facilitates delayed-release of the antibiotic in the colon. Aries Pharmaceuticals plans to launch the product during the first quarter of 2019. Pricing information has not been announced.