The FDA’s final guidance on developing drugs and biologics to treat chronic rhinosinusitis with nasal polyps shares considerations sponsors should make for trial design/population, safety, effectiveness and statistical analysis.

The guidance pertains specifically to chronic rhinosinusitis with nasal polyps, the FDA clarifies up front and does not apply to trials of products meant to treat allergic fungal rhinosinusitis or chronic rhinosinusitis without nasal polyps.

The 16-page guidance delves into:

• Trial population considerations, including recommended inclusion and exclusion criteria;
• Trial design recommendations;
• Efficacy considerations, including advised co-primary endpoints;
• Safety considerations;
• Corticosteroid-specific issues; and
• Drug-device combination product considerations.

The final guidance recommends that sponsors include patients with a variety of conditions, such as bilateral nasal polyps, ongoing nasal congestion with a specified duration and possibly nasal discharge and loss of smell.

For topical nasal formulations, the FDA recommends outlining the differences between placebo and active treatment, such as differences in the device, odor, taste, and formulation, in the protocol to help gauge blinding adequacy.

Access the full guidance here: https://bit.ly/3JPkh8d.