FDA Guidance Tackles Drug Trials for Chronic Rhinosinusitis

In a draft guidance released last week, the FDA offered advice for sponsors on the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).

The 13-page document, titled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment, highlights the FDA’s current recommendations regarding trial population, design, effectiveness, statistical analysis and safety for drugs being developed for the chronic condition that affects about 2.5 percent of adults.

The guidance provides general recommendations for clinical trial populations for CRSwNP investigational drug trials intended to provide evidence of safety and effectiveness to support a marketing application.

The agency encourages enrollment of pediatric subjects age 12 or older in clinical trials of adults and said sponsors should enroll subjects who reflect the characteristics of clinically relevant populations, including with regard to race and ethnicity.