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# FDA OKs Neffy Allergic Reaction Nasal Spray
- URL: https://www.fdaweb.com/fda-oks-neffy-allergic-reaction-nasal-spray/
- Published: 2024-08-09T12:00:00.000Z
- Updated: 2026-09-14T14:37:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157542

FDA has approved an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adult and pediatric patients. “Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” CDER Division of Pulmonology, Allergy and Critical Care associate director **Kelly Stone** is quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm%5Fmedium=email&utm%5Fsource=govdelivery) as saying. “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections.”

Neffy's approval was based on data from four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products, the agency says. “Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products,” it says. “Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis.”

FDA notes that neffy includes a warning that certain nasal conditions, such as nasal polyps or previous nasal surgeries, may affect the drug’s efficacy. It adds that patients with these conditions should talk to their physician to consider using neffy.