Travelers Diarrhea Has New Treatment Option
FDA Grants QIDP and Fast Track Designations for Aemcolo (Rifamycin SV MMX) for Travelers’ Diarrhea
The U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo (Rifamycin SV MMX®) for the treatment of patients with travelers’ diarrhea.
Travelers’ diarrhea (TD) is the most predictable travel-related illness.
Attack rates range from 30% to 70% of travelers, depending on the destination and season of travel. Traditionally, poor hygiene practice in local restaurants is likely the largest contributor to the risk for TD.
"We are pleased with the FDA’s decision to Fast Track Aemcolo and provide those who suffer from travelers’ diarrhea with a potentially new treatment option," said Tom Joyce, CEO of Aries Pharmaceuticals.
"Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and in some cases, it can progress to more serious conditions if not treated effectively,” said Joyce.
Fast Track is a process the FDA designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need.
Phase III clinical trials of Aemcolo in travelers’ diarrhea have been completed in the U.S. and EU. The Phase III program demonstrated Aemcolo’s superiority as compared to a placebo and its non-inferiority as compared to Ciprofloxacin.
Aemcolo is a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic which can be used for the treatment of bacterial infections of the colon such as travelers’ diarrhea.
The application of MMX technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract.
The specific dissolution profile of Aemcolo tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus abating its systemic absorption in the small intestine.
TD is a clinical syndrome that can result from a variety of intestinal pathogens. Bacterial pathogens are the predominant risk, thought to account for up to 80%–90% of TD.
Intestinal viruses usually account for at least 5%–8% of illnesses, although improved diagnostics may increase recognition of norovirus infections in the future, according to the Centers for Disease Control and Prevention.
What is commonly known as “food poisoning” involves the ingestion of preformed toxins in food. In this syndrome, vomiting and diarrhea may both be present, but symptoms usually resolve spontaneously within 12 hours.
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