FDA approves Aemcolo for travelers’ diarrhea

The FDA announced that it has approved Aemcolo for the treatment of travelers’ diarrhea caused by noninvasive Escherichia coli strains in adults.

Travelers’ diarrhea affects approximately 10% to 40% of travelers worldwide each year, making it the most common travel-related illness, according to the FDA. People traveling to areas in Asia, the Middle East, Africa, Mexico and Central and South America have the greatest risk for contracting the disease.

The FDA based its approval of Aemcolo (rifamycin, Cosmo Pharmaceuticals) on findings from a randomized controlled clinical trial that showed that the drug significantly reduced symptoms of travelers’ diarrhea compared with placebo among 264 adults in Guatemala and Mexico.

The safety of an oral rifamycin regimen administered over 3 or 4 days was assessed in more than 600 adults. The most common adverse reactions included headache and constipation, the FDA reported.

Rifamycin lacks efficacy against diarrhea complicated by a fever or blood in patients’ stool and therefore is not recommended for patients with these conditions. The FDA also warned that it should be not administered to patients with a known hypersensitivity to any components of rifamycin, as well as any other rifamycin class, such as Xifaxan (rifaximin, Salix Pharmaceuticals).

Rifamycin was previously granted qualified infectious disease product designation in October 2017.

Reference:

FDA. FDA approves new drug to treat travelers’ diarrhea. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626121.htm. Accessed Nov. 16, 2018.