Rifamycin (Aemcolo), an antibacterial drug indicated for the treatment of adults with travelers' diarrhea was approved by the U.S. Food and Drug Administration (FDA).
Rifamycin SV MMX® is a non-absorbable rifamycin antibiotic formulated using the multi-matrix system designed to exhibit its pharmacological action on the distal small intestine and colon.
"Travelers' diarrhea affects millions of people each year and having treatment options for the condition," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research .
Travelers' diarrhea is the most common travel-related illness, affecting an estimated 10 to 40 percent of all international travelers every year. The highest-risk destinations are located in Asia as well as the Middle East, Africa, Mexico, and Central and South America.
Travelers' diarrhea is defined by 3 or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most common bacteria are found in food and water.
The efficacy of Aemcolo was demonstrated in a randomized, placebo-controlled clinical trial in 264 adults with travelers' diarrhea in Guatemala and Mexico.
The Phase III program demonstrated Aemcolo's superiority as compared to a placebo and its non-inferiority as compared to Ciprofloxacin.
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The most common adverse reactions with Aemcolo were a 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.
Aemcolo should not be used in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (eg rifaximin), or any of the components in Aemcolo.
During 2017, the FDA awarded Aemcolo a Qualified Infectious Disease Product (QIDP) designation.
QIDP designation is given to antibacterial and antifungal drug products that treat serious or life-threatening infections.
As part of QIDP designation, the Aemcolo marketing application was given priority review under which the FDA's goal is to take action on an application within an expedited time frame.
The FDA granted approval of Aemcolo to Cosmo Technologies, Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.