The FDA approves an antibacterial drug for treating diarrhea



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The US Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial agent, indicated for the treatment of adult patients with diarrhea caused by non-invasive strains Escherichia coli (E. coli), which is not complicated by fever or blood in the stool.

"Traveler's diarrhea affects millions of people every year and have treatment options for this condition can help to reduce the symptoms of the condition," said Edward Cox, MD, MPH, Director of the Antimicrobial Center for the Evaluation and Research of Medicines.

Traveler's diarrhea is the most common travel-related illness that affects about 10 to 40 percent of travelers every year worldwide. Traveler's diarrhea is defined by three or more untreated cushions within 24 hours in a traveler. It is caused by various pathogens, and most commonly bacteria in food and water. The most risky destinations are in most of Asia, but also in the Middle East, Africa, Mexico and Central and South America.

The efficacy of Aemcolo was demonstrated in a randomized placebo-controlled clinical trial of 264 adults with traveling diarrhea in Guatemala and Mexico. It has been shown that Aemcolo significantly reduced the symptoms of travel diarrhea compared to placebo.

The safety of Aemcolo administered orally in three or four days was evaluated in 619 adults with travel diarrhea in two controlled clinical trials. The most common side effects of Aemcolo were headache and constipation.

Aemcolo was not effective in patients with diarrhea complicated by fever and / or bloody sludge 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 rifamycin, any other antifung agent of rifamycin (for example, rifaximin) or any of the other ingredients of Aemcolo.

FDA approved Aemcolo Qualified Infectious Disease Product (QIDP). The QIDP code is intended for antibacterial and antifungal medicinal products that deal with serious or life-threatening infections in accordance with the FDA Protection and Innovation Act for Generating Antibiotic Injections Today (GAIN). Under the QIDP tag, the Aemcolo marketing application was approved as a priority, according to which the FDA's goal is to act in a fast-paced role.

The FDA approved Aemcolo for Cosmo Technologies, Ltd.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626121.htm

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