FDA removes age restriction for epinephrine nasal spray

The FDA has approved an update to 1 mg epinephrine nasal spray (Neffy; ARS Pharmaceuticals) to remove the age criteria, allowing all patients weighing at least 33 lb to access the therapy regardless of age, according to ARS Pharmaceuticals.¹

Epinephrine nasal spray is an emergency treatment of type 1 allergic reactions, including anaphylaxis. Alongside the weight requirement, an age requirement of at least 4 years was previously necessary to use this treatment. However, the update has removed this requirement, alongside recommending patients carry epinephrine nasal spray in the blister packaging or the designated carrying case.

“Severe allergic reactions are a major concern in early childhood and parents often delay treatment because they are afraid of hurting their child with a needle-injector or accidentally injecting themselves,” said Nicole Chase, MD, a board certified allergy/immunology and pediatrics specialist at St. Paul Allergy & Asthma.

Revised administration guidelines

These FDA updates also made guidance around sniffing, temperature excursions, and freezing more flexible. This includes clarifying that even management does not differ based on whether a patient sniffs in after epinephrine nasal spray administration, and that additional dosing is not necessary if symptoms improve within 5 minutes.

Additionally, the update clarifies that if the nasal spray has accidentally been frozen, it may still be used after being thawed. Temperature excursions up to 122 ^oF are also allowed.

The 1-mg dose of epinephrine nasal spray has been indicated for patients weighing at least 33 lb and under 66 lb. In patients weighing at least 66 lb, a 2-mg dose is recommended. Experts recommend that patients always have 2 doses in close access in case symptoms come back following the first dose.

“Having a needle-free epinephrine treatment available for anyone who meets the weight criteria is an important step forward, in broadening access, lowering treatment hurdles, and supporting caregivers who are doing everything they can to protect their children,” said Chase.

First-line therapeutic protocol

The importance of quick epinephrine use for anaphylaxis has been highlighted by Alice Hoyt, MD, FAAAI, a board-certified allergist and immunologist and founding partner of the Early Childhood Anaphylaxis Collaborative, in an interview with Contemporary Pediatrics.²

According to Hoyt, epinephrine must be first-line therapy because antihistamines cannot stop the underlying cellular cascade. Epinephrine devices are designed to be user-friendly and provide the necessary amount of therapy to treat patients, making use vital as soon as anaphylaxis is recognized.

Hoyt highlighted food allergies as the most common cause of anaphylaxis in children. To counter this, early recognition and immediate intervention is necessary. This makes epinephrine nasal spray vital as a needle-free option.

Real-world efficacy and comparability data

Additionally, epinephrine nasal spray’s efficacy has been highlighted by real-world data in a study of 545 patients. Of this population, 89.2% achieved symptom resolution from a single dose of epinephrine spray.

This efficacy is noninferior to epinephrine intramuscular injection or auto-injector, which had a symptom resolution rate of 88.9%. Based on these results, the FDA initially approved epinephrine nasal spray in August 2024, leading to positive reception in the allergy and immunology community.

“The most important thing is as soon as [you recognize] that it is anaphylaxis, you’re treating it promptly with epinephrine,” said Hoyt.

References

1. ARS Pharmaceuticals receives FDA approval to remove age requirement from Neffy 1 mg (epinephrine nasal spray) label. News release. ARS Pharmaceuticals. March 27, 2026. Accessed March 27, 2026. https://www.globenewswire.com/news-release/2026/03/27/3263722/0/en/ARS-Pharmaceuticals-Receives-FDA-Approval-to-Remove-Age-Requirement-From-neffy-1-mg-epinephrine-nasal-spray-Label.html
2. Hoyt A. Alice Hoyt, MD, discusses the importance of quick epinephrine use for anaphylaxis. Contemporary Pediatrics. November 19, 2025. Accessed March 27, 2026. https://www.contemporarypediatrics.com/view/alice-hoyt-md-discusses-the-importance-of-quick-epinephrine-use-for-anaphylaxis