ARS Pharmaceuticals submits response to FDA’s CRL for neffy nasal spray

ARS Pharmaceuticals announced that it has submitted its response to the U.S. Food and Drug Administration FDA for its New Drug Application NDA for neffy or epinephrine nasal spray , for the treatment of Type I allergic reactions including anaphylaxis. The submission follows receipt of a Complete Response Letter or 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of neffy under nasal allergen challenge NAC conditions, and completion of updated nitrosamine testing per the FDA’s draft guidance issued in August 2023.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. “Based on multiple meetings with the FDA, we believe that we have responded fully and completely to the Agency’s concerns and appreciate its insights along the way. ” ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2 based on the submission receipt date of April 2.