ARS Pharmaceuticals, Inc. announced that it has submitted its response to the U.S. Food and Drug Administration for its New Drug Application for neffy® (epinephrine nasal spray), for the treatment of Type I allergic reactions including anaphylaxis. The submission follows receipt of a Complete Response Letter (CRL) from the FDA in September 2023, which identified two additional requests: completion of a repeat dose pharmacokinetic (PK) /pharmacodynamic (PD) study of neffy under nasal allergen challenge conditions, and completion of updated nitrosamine testing per the FDA?s draft guidance issued in August 2023. In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected. The original neffy NDA was submitted in August 2022. In May 2023, the FDA Advisory Committee determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).

No PADAC member requested a repeat dose study during allergen-induced allergic rhinitis.