The US Food and Drug Administration (FDA) recently approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travellers’ diarrhoea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
‘Travellers’ diarrhoea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition,’ said Edward Cox, MD, MPH, Director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research.
Travellers’ diarrhoea is the most common travel-related illness, affecting an estimated 10-to-40 per cent of travellers worldwide each year.
Travellers’ diarrhoea is defined by having three or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most commonly bacteria found in food and water. The highest 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 in a randomised, placebo-controlled clinical trial in 264 adults with travellers’ diarrhoea 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. The most common adverse reactions with Aemcolo were headache and constipation.
