The approval is based on two Phase 3 clinical trials which demonstrated that the drug was at least as effective as nitrofurantoin ... moderate gastrointestinal side effects being the most common.

Side effects were reported by 27% of women in ... a 3-day course of a fluoroquinolone or a 7-day course of nitrofurantoin is appropriate.

In EAGLE-2, gepotidacin was non-inferior to nitrofurantoin ... The most commonly reported side effects on the new antibiotic were diarrhoea and nausea. Analysts forecast global annual sales ...