Travellers’ diarrhoea, defined as 3 or more unformed stools in a span of 24 hours in a person who is traveling, affects about 40% of the international travellers. Rifamycin, an antibacterial drug indicated for the treatment of adults with travellers’ diarrhoea was approved by the U.S. FDA. The formulation is a non-absorbable rifamycin antibiotic with multi-matrix systems.
Drug efficacy was established in a randomized, placebo-controlled clinical trial in 264 adults with travellers’ diarrhoea in Guatemala and Mexico. Safety assessment comprised of two trials when the drug was administered over 3 or 4 days in 619 adults. The most common issues associated with the drug were constipation and headache. The anti-bacterial drug is permitted to treat traveller’s diarrhoea caused by strains of Escherichia coli that do not involve fever or blood in the stool and is to be administered orally.…