PNP perspective: Nasal epinephrine spray approved for children as young as 4 years

Nasal epinephrine spray approved for children as young as 4-years-old | Image Credit: © CreativeSuburb - stock.adobe.com.

I was excited to hear the announcement on March 5^th 2025, that the United States Food and Drug Administration (FDA) approved the 1 mg epinephrine nasal spray, called neffy, produced by ARS Pharmaceuticals Inc (ARS Pharma) for children 4-years-old and older whose weight is between 33 to 66 lbs. Children who experience anaphylactic reactions will be less fearful during the reaction, knowing that they no longer require an epinephrine injection and that they will feel better quickly with neffy, an easy-to-administer nasal spray.

Educating providers and parents about Neffy

When new medications become available, pediatric nurse practitioners (PNPs) must become familiar with product details as well as the information that must be shared with parents, so the medication is accurately administered. ARS Pharma created a detailed website for both health care providers and parents¹: https://www.neffy.com/how-to-use/?gad. The specific technique for administering the nasal spray is also available on this website and should be reviewed with the parent. The PNP should read the instructions with the parents and have the parents demonstrate how to hold the device in their hand, and the approved way to position the device in the nostril before and during administration. Parents also need to review the signs of an anaphylactic reaction and talk about their previous experiences recognizing the symptoms, administering the medication, to correcting any problems they may have encountered.

The parents should be informed that each nasal spray device has only one dose of nasal epinephrine in it, thus, they must always carry 2 neffy nasal sprays with them. Like the injectable epinephrine, more than one dose of the nasal epinephrine may be needed to reverse an anaphylactic reaction.

Since neffy is available for children 4 years old, two nasal spray devices should also be available at a daycare center or preschool that the child attends. The parents would need to supply these doses to the daycare or preschool. ARS Pharma has launched the neffyinSchools Program to assure that all private and public K-12 schools in the U.S. can receive two cartons for free that contain four single use neffy doses to use in emergencies. PNPs and all providers in schools and School-Based Health Centers (SBHCs) should be aware of the neffyinSchools Program and of their state laws for stocking epinephrine in schools. More information about the schools and state laws is also available on their website.¹

Information for health care professionals

The website also contains prescribing and safety information, and a healthcare professionals-only site (https://neffypro.com/).²

Educating everyone in the pediatric office

Pediatric offices usually have scheduled times every few months to ‘practice’ office-based procedures for managing emergencies in the office setting. Best practice would be to introduce the 1 mg dose of neffy for use in office emergencies during one of the planned practice sessions, so that all members of the pediatric office team have a role during an emergency and know the location and use protocols for neffy in the office. Creating an office-based educational plan for discussion with parents is an essential part of office-based practices. The educational plan should include information that neffy is only for use in the nose. Neffy should be used as soon as symptom of an allergic reaction is observed. A second dose using a new neffy can be administered in the same nostril 5 minutes after the first dose, if the first dose did not effectively resolve the symptoms.³ Parents should be informed by the provider as to their office protocol for calling for emergency assistance once the first dose is administered. Neffy 1 mg is expected to be available by the end of May 2025.

References:

1. How to use neffy. 2025. Accessed April 22, 2025. https://www.neffy.com/how-to-use/?gad

2. Neffy (epinephrine nasal spray). Site intended for US Healthcare Professionals Only. 2025. Neffy. Accessed April 22, 2025. https://neffypro.com/

3. ARS Pharmaceuticals. ARS Pharmaceuticals announces FDA approval of neffy 1 mg (epinephrine nasal spray for Type I allergic reactions, including anaphylaxis, in pediatric populations weighing 15 to < 30 kilograms. ARS Pharmaceuticals. March 5, 2025. Accessed April 22, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg/#:~:text=neffy%20is%20for%20use%20in,minutes%20after%20the%20first%20dose.