One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment

On August 9, 2024, the FDA approved the first needle-free epinephrine nasal spray under the name neffy (ARS Pharmaceuticals) for the emergency treatment of anaphylaxis in adults and children—a significant milestone in allergy care.1 One year later, this intranasal option has expanded the treatment landscape for severe allergic reactions, offering a discreet and easy-to-use alternative to autoinjectors. For many patients, especially children or those with needle aversion, this innovation represents not just convenience, but potentially life-saving accessibility.

Over the past year, clinicians have gained real-world experience with intranasal epinephrine, now approved for use in patients as young as 4 years old and weighing between 15 to <30 kg, following an FDA expansion in March 2025.2 While some access barriers remain typical for newly approved therapies, early adoption has been encouraging, with over 5,000 prescriptions written since approval, although data is not available regarding how many have actually been filled.3

This first year has offered an opportunity to assess insurance coverage patterns, patient adherence, and clinician comfort in prescribing a new route of epinephrine delivery. As more needle-free options enter the pipeline, continued education for clinicians will be critical to ensure familiarity with evolving treatment modalities and appropriate patient selection.

Overall, in its first year since coming to market, nasal epinephrine seems to be an invaluable addition to the anaphylaxis treatment landscape. Long-term data will continue to validate patient use.

Brief descriptions of the speakers featured in this project are provided below:

Matthew Greenhawt, MD, MBA, MSc: CMO of Asthma and Allergy Foundation of America (AAFA), former professor at Childrens' Hospital Colorado and University of Colorado

Brian Schroer, MD: Allergist immunologist at the Cleveland Clinic Children's Hospital

Colleen Kraft, MD, MBA: Clinical professor of Pediatrics at the Keck School of Medicine of USC and an attending physician at the Children’s Hospital Los Angeles

Ryan Haumschild, PharmD, MS, MBA: Vice President of Pharmacy at Emory Healthcare and Winship Cancer Institute

Thomas Casale, MD: Professor of Medicine at University of South Florida in Tampa

Editors' note: The video states neffy 2 mg is approved for adults or children weighing ≥ 66 pounds. However, neffy 2mg is approved for adults and children weighing ≥ 66 pounds, and the 1 mg version is approved for patients aged ≥ 4 years who weigh between 33 and 66 pounds.

REFERENCES

1. Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.
   ARS Pharmaceuticals.

2. 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. ARS Pharmaceuticals. March 5, 2025. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg.

3. ARS Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Progress in U.S. Commercial Launch of neffy® (epinephrine nasal spray). News release. ARS Pharmaceuticals. May 14, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-reports-first-quarter-2025-financial-results