FDA Rejects Neffy Epinephrine Nasal Spray for Severe Allergic Reactions

The FDA has declined to approve Neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, citing the need for more trial data to evaluate the safety of repeated doses. Neffy, which would provide a needle-free option for treating severe allergic reactions, was expected to be approved for use in adults and children weighing over 30 kilograms. The decision comes as a disappointment to many families of children with severe allergies who prefer to avoid needles. The drugmaker plans to conduct the requested trial as quickly as possible to meet the needs of patients.