Epinephrine Nasal Spray as Effective as Injection for Anaphylaxis in Real-World Data

Real-world data has demonstrated that ARS Pharmaceuticals' epinephrine nasal spray (neffy) is as effective as epinephrine injections for anaphylaxis.1 This first large-scale analysis of treatment outcomes with epinephrine nasal spray during routine clinical practice will be published in Annals of Allergy, Asthma, and Immunology, the official journal of the American College of Allergy, Asthma, and Immunology.

“The finding that about 9 out of every 10 patients were successfully treated with a single dose of neffy in more than 500 patients is essentially identical to the historic response rates observed with epinephrine injection,” Thomas B. Casale, MD, professor of Medicine and Pediatrics and chief of Clinical and Translational Research in the USF Health Morsani College of Medicine at the University of South Florida, said in a statement.1 “We believe these real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection, building on the clinical studies conducted for FDA approval that showed neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”

Type I allergic reactions can be life-threatening and require immediate epinephrine, yet many patients delay or avoid using auto-injectors due to barriers like fear of needles, portability issues, and device complexity. In 2023, for example, of the 20 million people treated for severe reactions, only 3.2 million filled an auto-injector prescription, and just half of those consistently carried it.

In 2024, the US Food and Drug Administration (FDA) approved epinephrine nasal spray for type 1 allergic reactions, including anaphylaxis, in adults and children aged ≥ 4 years who weigh ≥ 33 lbs.2 Common adverse events include nasal discomfort, headache, throat irritation, chest and nasal congestion, over-excitement, nervousness, nosebleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, exhaustion, dizziness, nausea, and vomiting.1

A recent observational analysis evaluated real-world use of epinephrine nasal spray versus epinephrine injection, the historical control, in routine practice.1 Investigators administered the nasal spray to 545 participants during an oral food challenge or allergen immunotherapy, with data collected through March 2025.

Healthcare providers (n = 301) in the neffy experience program, who received 6 doses of epinephrine nasal spray, reported data on its use for rescuing patients experiencing anaphylaxis symptoms during these challenges.1 Following epinephrine nasal spray labeling, providers may administer a second dose if anaphylaxis symptoms persist or worsen 5 minutes after the first dose.

The team collected historic controls (n = 12,615) from a 2021 study led by Nandinee Patel, MD, from the National Heart and Lung Institute at Imperial College London.1 These controls received an epinephrine injection during food-induced anaphylaxis.

A single dose of epinephrine nasal spray 2 mg successfully treated 486 patients, with 59 requiring a second dose.1

Compared to the epinephrine injection’s 88.9% success rate, a single dose of epinephrine nasal spray resulted in an 89.2% success rate.1

ARS Pharmaceuticals noted potential limitations of this observational analysis, drawing attention to the lack of randomization, uniform timing or type of clinical assessments, and challenges with missing data.1 The neffy experience program continues to evaluate the effectiveness of real-world epinephrine nasal spray, exploring 2 mg and 1 mg doses.

“Findings from this real-world report align with the positive impact that I have seen firsthand in my own patients treated with neffy,” said Jonathan M. Spergel, MD, PhD, professor of pediatrics and chief of the allergy program at Children’s Hospital of Philadelphia.1 “I believe my patients have benefitted from a product with the same clinical performance as an epinephrine injection, but in a needle-free, portable, and easy-to-use design that gives them peace of mind.”

References

1. Real-World Evidence Supports Clinical Effectiveness of neffy® (epinephrine nasal spray) in Patients Experiencing Anaphylaxis - ARS Pharmaceuticals. ARS Pharmaceuticals. Published 2025. Accessed September 12, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/real-world-evidence-supports-clinical-effectiveness-neffyr

2. Greenhawt M, Schroer B, Kraft C, et al. One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment. Hcplive. Published August 8, 2025. Accessed September 12, 2025. https://www.hcplive.com/view/one-year-later-how-intranasal-epinephrine-is-changing-emergency-allergy-treatment