FDA accepts ARS Pharma's NDA for neffy (epinephrine nasal spray) for allergic reactions

ARS Pharmaceuticals, Inc.

FDA accepted NDA for neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis in adults and children ≥30 kg.
If approved, neffy would be first non-injectable treatment for type I allergic reactions in U.S.
PDUFA target action date anticipated in mid-2023.
NDA based on four registration studies showing pharmacokinetics comparable to injectable epinephrine; well-tolerated in over 500 individuals.
Acceptance is a milestone for Silverback's proposed merger with ARS Pharma (previously announced).

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