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The American Food and Drug Administration has today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with diarrhea caused by non-invasive Escherichia coli (It's coli) that are not complicated by fever or blood in the stool.
"Travelers' 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 Antimicrobial Office at the FDA Center for Drug Evaluation and Research .
Passenger Diarrhea is the most common travel-related illness, affecting around 10 to 40% of travelers around the world each year. Passenger Diarrhea is defined by having three or more unformed seats in 24 hours for a person traveling. It is caused by a variety of pathogens, but most often bacteria are found in food and water. The biggest destinations at risk are in most Asian countries, as well as in the Middle East, Africa, Mexico, Central and South America.
The efficacy of Aemcolo has been demonstrated in a randomized, placebo-controlled clinical study in 264 adults with diarrhea in Guatemala and Mexico. He showed that Aemcolo significantly reduced the symptoms of travelers' diarrhea compared to placebo.
The safety of administering Aemcolo, given orally for three or four days, was evaluated in 619 adults with diarrhea in two controlled clinical trials. The most common side effects with Aemcolo were headache and constipation.
Aemcolo has not been shown to be effective in patients with complicated diarrhea of fever and / or bloody stool or diarrhea due to pathogens other than non-invasive E. coli strains and is not recommended for use in these patients. Aemcolo should not be used in patients with known hypersensitivity to rifamycine, any of the other antimicrobials of the rifamycins class (eg rifaximin) or any of the ingredients in Aemcolo.
The FDA has granted Aemcolo a product name for Qualified Infectious Disease (QIDP). The QIDP is a description of antibacterial and antifungal products that treat serious or life-threatening infections under the Generation Antibiotic Incentives Now (GAIN) Act. As part of the QIDP designation, the Aemcolo marketing application was granted a priority review, according to which the FDA's purpose is to act on an application within a shipment time.
FDA has granted Aemcolo approval to Cosmo Technologies, Ltd.
Source:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626121.htm
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