FDA Approves New Drug for Traveler's Diarrhea (Aemcolo)

Megan Brooks

Disclosures

November 19, 2018

The US Food and Drug Administration (FDA) has approved the antibacterial agent rifamycin delayed-release tablets (Aemcolo, Cosmo Technologies) to treat adults with travelers’ diarrhea caused by noninvasive strains of Escherichia coli not complicated by fever or blood in the stool.

"Travelers' diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," Edward Cox, MD, director of the Office of Antimicrobial Products, FDA Center for Drug Evaluation and Research, said in a news release.  

Travelers' diarrhea is defined by having three or more unformed stools in 24 hours in a person who is traveling. The highest-risk destinations are most of Asia as well as the Middle East, Africa, Mexico, and Central and South America.

In a randomized, placebo-controlled clinical trial involving 264 adults with travelers' diarrhea in Guatemala and Mexico, Aemcolo significantly reduced symptoms of travelers' diarrhea compared with placebo, the FDA said.

The safety of Aemcolo, taken orally over 3 or 4 days, was evaluated in 619 adults with travelers' diarrhea in two controlled clinical trials. The most common adverse reactions with Aemcolo were headache and constipation.

"Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients," the FDA said.

Aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin or any of the components of Aemcolo, as well as any of the other rifamycin class antimicrobial agents, such as rifaximin (Xifaxan, Salix Pharmaceuticals).

The FDA granted Aemcolo priority review and qualified infectious disease product (QIDP) designation. QIDP designation is given to antibacterial and antifungal products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

Aemcolo will be available in pharmacies in the first quarter of 2019, the company said in a news release.  

"Given the potential seriousness of travelers' diarrhea and growing resistance to antibiotics that have been in widespread use since the early '90s, it's important to have a new option for treatment. Because Aemcolo is a minimally absorbed, colon-targeted antibiotic, it will be an important new option for patients," Herbert Dupont, MD, professor for infectious diseases at the University of Texas Houston School of Public Health, who worked on the Aemcolo studies, said in the release.

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