FDA Releases Final Guidance on Drugs for Hay Fever, Non-Allergic Rhinitis

The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances released Wednesday, the agency urges drug sponsors to focus on real-world settings when trying to determine ideal doses.

Sponsors should target the specific subtype of rhinitis — or symptoms — they hope to address, which may require them to run preliminary studies to narrow the scope. The FDA will be open to alternative trial designs to the traditional phase I, II and III model, the guidance states.

For instance, the agency would prefer sponsors to test proposed drugs under real-life conditions, but it’s open to “alternative exposure models,” though the guidance doesn’t offer specifics on other potential trial designs.