FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development

Drugmakers developing treatments for uncomplicated vulvovaginal candidiasis should conduct two adequate and well-controlled clinical trials with a superiority design to demonstrate efficacy, the FDA recommends.

In draft guidance, the agency suggested that these trials be randomized, double-blinded and either placebo-controlled or active-controlled.

Specimens collected for microbiologic evaluation should specifically be examined for yeast and tested for susceptibility to appropriate antifungal drugs, the FDA recommends.