Intranasal Epinephrine Is Approved for Younger Children

A lower dose of intranasal epinephrine is now available for children as young as 4 years.

Background

In August 2024, the U.S. Food and Drug Administration approved a 2-mg epinephrine nasal spray (“neffy”) for adults and children who weigh ≥30 kg (≥66 lb; NEJM JW Gen Med Sep 15 2024). Now, in March 2025, a lower-dose 1-mg epinephrine nasal spray has been approved for pediatric patients who are 4 years or older and who weigh 15 to 30 kg (33–65 lb). Of note, National Institute of Allergy and Infectious Diseases guidelines recommend increasing the dose of intramuscular epinephrine from 0.15 mg to 0.3 mg at 25 kg rather than 30 kg (J Allergy Clin Immunol 2010; 126:1105).

Studies that led to FDA approval

In addition to extrapolation from adult studie…