Public health agency the US Food and Drug Administration reported on Friday that it has approved Aemcolo (rifamycin) for the treatment of adult patients with travellers diarrhoea under its Qualified Infectious Disease Product (QIDP) designation.
The agency has approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travellers diarrhoea caused by noninvasive strains of Escherichia coli (E. coli). Travellers diarrhoea is the most common travel-related illness, affecting an estimated 10 to 40 % of travellers worldwide each year. The highest-risk destinations are in most of Asia as well as the Middle East, Africa, Mexico and Central and South America.
In addition, the US FDA has granted approval of Aemcolo to Cosmo Technologies Ltd.
According to the agency, the efficacy of Aemcolo was demonstrated in a randomised, placebo-controlled clinical trial in 264 adults with travelers' diarrhea in Guatemala and Mexico. It showed that Aemcolo significantly reduced symptoms of travellers diarrhoea compared to the placebo. The safety of Aemcolo, taken orally over three or four days, was evaluated in 619 adults with travellers diarrhoea in two controlled clinical trials.
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