Today's US Food and Drug Administration approves Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with tourist diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
"Traveler diarrhea affects millions of people every year and having treatment options for this condition can help reduce the symptoms of the condition," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products at the FDA Center for Drug Evaluation and Research.
Traveler diarrhea is the most travel-related disease, which affects around 10 to 40 percent of travelers worldwide every year. Diarrhea travelers are defined as having three or more formless feces in 24 hours, to someone who is traveling. This is caused by various pathogens, but most often bacteria are found in food and water. The highest risk destinations are in most parts of Asia and the Middle East, Africa, Mexico and Central and South America.
The efficacy of Aemcolo was shown in randomized placebo-controlled clinical trials in 264 adults with diarrhea travelers in Guatemala and Mexico. This shows that Aemcolo significantly reduces traveler's diarrhea symptoms compared to placebo.
The Aemcolo safety, taken orally for three or four days, was evaluated in 619 adults with diarrhea travelers in two controlled clinical trials. The most common side effects with Aemcolo are headaches and constipation.
Aemcolo is not proven effective in patients with diarrhea complicated by bloody fever and / or feces or diarrhea because pathogens other than E. coli strains are non-invasive and are not recommended for use in these patients. Aemcolo should not be used in patients with known hypersensitivity to rifamycin, one of the other rifamycin antimicrobial agents (eg rifaximin), or one component in Aemcolo.
The FDA gave Aemcolo the marking of Quality Infectious Disease Products (QIDP). The determination of QIDP is given to antibacterial and antifungal drug products that treat serious or life-threatening infections under the heading Generating Antibiotic Incentives Now (GAIN) of the FDA Safety and Innovation Act. As part of the QIDP designation, the Aemcolo marketing application was given a Priority Review where the FDA's goal was to take action on applications in an accelerated time frame.
The FDA gave Aemcolo approval to Cosmo Technologies, Ltd.