FDA Finalizes Guidance Supporting Superiority Trials for ABS Drugs

Sponsors of clinical studies for antimicrobial drugs to treat acute bacterial sinusitis (ABS) should use superiority trials and demonstrate that the candidate affects the clinical course of the disease, according to finalized FDA guidance on the topic. The final document’s proposed trial population is also less specific than the draft. Whereas the draft recommends enrolling male and female patients 12 years old and older, the final version simply recommends including patients of both genders and multiple races.
Washington Drug Letter