ARS Pharma Submits Addl. Data In Response To FDA's CRL For Neffy

(RTTNews) - ARS Pharmaceuticals, Inc. (SPRY) announced on Wednesday that it has submitted its response to the Complete Response Letter or CRL from FDA for its New Drug Application for Neffy also known as epinephrine nasal spray, to treat Type I allergic reactions, including anaphylaxis.

The company's response addresses all additional requests made by the FDA following the CRL in September 2023.

This includes positive data from a repeat dose PK/PD study of Neffy under nasal allergen challenge conditions, as well as updated testing that found no detectable nitrosamine levels.

The company expects the FDA review to last up to six months, with the PDUFA date set for October 2, 2024.