ARS Pharmaceuticals, Inc., trading under the symbol SPRY, reported on Wednesday that it has delivered its rejoinder to the Complete Response Letter (CRL) from the Food and Drug Administration regarding its New Drug Application for Neffy, also known as an epinephrine nasal spray. This product aims to treat Type I allergic reactions, including serious events like anaphylaxis.
The corporation's response catered to all further appeals elicited by the FDA, following the CRL in September 2023. New inclusions are affirmative results from a duplicated dosage pharmacokinetics/pharmacodynamics (PK/PD) investigation of Neffy in the context of nasal allergen provocation conditions. Additionally, updated examinations that identified no traceable levels of nitrosamine were included.
ARS Pharmaceuticals estimates that the FDA's review process could span six months, with the Prescription Drug User Fee Act (PDUFA) date designated as October 2, 2024.
