FDA approves new drug to treat travelers’diarrhea

日期:2019-01-03 作者:林佑 来源:FDA

November 16, 2018

The U.S. Food and Drug Administration todayapproved Aemcolo (rifamycin), an antibacterial drug indicated for the treatmentof adult patients with travelers’ diarrhea caused by noninvasive strains ofEscherichia coli (E. coli), not complicated by fever or blood in the stool.

"Travelers' diarrhea affects millionsof people each year and having treatment options for this condition can helpreduce symptoms of the condition," said Edward Cox, M.D., M.P.H., directorof the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluationand Research.

Travelers' diarrhea is the most commontravel-related illness, affecting an estimated 10 to 40 percent of travelersworldwide each year. Travelers' diarrhea is defined by having three or moreunformed stools in 24 hours, in a person who is traveling. It is caused by avariety of pathogens, but most commonly bacteria found in food and water. Thehighest-risk destinations are in most of Asia as well as the Middle East,Africa, Mexico, and Central and South America.

The efficacy of Aemcolo was demonstrated ina randomized, placebo-controlled clinical trial in 264 adults with travelers’diarrhea in Guatemala and Mexico. It showed that Aemcolo significantly reducedsymptoms of travelers’ diarrhea compared to the placebo.

The safety of Aemcolo, taken orally overthree or four days, was evaluated in 619 adults with travelers’ diarrhea in twocontrolled clinical trials. The most common adverse reactions with Aemcolo wereheadache and constipation.

Aemcolo was not shown to be effective inpatients with diarrhea complicated by fever and/or bloody stool or diarrhea dueto pathogens other than noninvasive strains of E. coli and is not recommendedfor use in such patients. Aemcolo should not be used in patients with a knownhypersensitivity to rifamycin, any of the other rifamycin class antimicrobialagents (e.g. rifaximin), or any of the components in Aemcolo.

The FDA granted Aemcolo a QualifiedInfectious Disease Product (QIDP) designation. QIDP designation is given toantibacterial and antifungal drug products that treat serious orlife-threatening infections under the Generating Antibiotic Incentives Now(GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation,the Aemcolo marketing application was granted Priority Review under which theFDA’s goal is to take action on an application within an expedited time frame.

The FDA granted approval of Aemcolo toCosmo Technologies, Ltd.

The FDA, an agency within the U.S.Department of Health and Human Services, protects the public health by assuringthe safety, effectiveness, security of human and veterinary drugs, vaccines andother biological products for human use, and medical devices. The agency isalso responsible for the safety and security of our nation’s food supply,cosmetics, dietary supplements, products that give off electronic radiation,and for regulating tobacco products.

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