FDA

Lower dose neffy OK’d for patients weighing less than 30 kg

March 11, 2025

FDA approved neffy 1 mg (epinephrine nasal spray) for the treatment of type I allergic reactions, including anaphylaxis, in children ≥4 years of age weighing 15 to <30 kg.

The 2-mg formulation of neffy was approved in 2024 for children and adults weight ≥30 kg.

Efficacy

Approval of neffy 1 mg was based on data from clinical trials, including pharmacokinetic and pharmacodynamic responses in pediatric and adult subjects that were consistent with those of injectable epinephrine products.

Safety

The most common adverse reactions in pediatric patients weighing ≥15kg were nasal discomfort, nasal congestion, paresthesia, rhinorrhea, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.

Sources:

ARS Pharmaceuticals. neffy (epinephrine nasal spray) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697s001lbl.pdf. Revised March 2025. Accessed March 10, 2025.

ARS Pharmaceuticals Announces FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms. [News release]. ARS Pharmaceuticals. 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg