ARS Pharmaceuticals Submits Response to FDA Letter for Neffy

Dow Jones04-03

By Chris Wack

ARS Pharmaceuticals has submitted its response to the U.S. Food and Drug Administration for its New Drug Application of neffy epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis.

The submission follows receipt of a Complete Response Letter from the FDA in September 2023, which identified two additional requests: completion of a repeat dose pharmacokinetic/pharmacodynamic 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of neffy under nasal allergen challenge $(NAC)$ conditions, and completion of updated nitrosamine testing per the FDA's draft guidance issued in August 2023.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 successfully completed 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 committee member requested a repeat dose study during allergen-induced allergic rhinitis.

ARS Pharma sees an FDA review period of up to six months, and the PDUFA date is anticipated to be Oct. 2, 2024, based on the submission receipt date of April 2, 2024.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 03, 2024 09:18 ET (13:18 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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