Neffy demonstrates positive, real-world data for anaphylaxis | Image Credit: © MQ-Illustrations - © MQ-Illustrations - stock.adobe.com.

ARS Pharmaceuticals, Inc announced real-world evidence supporting the effectiveness of neffy (epinephrine nasal spray) in treating anaphylaxis symptoms in patients undergoing oral food challenge or allergen immunotherapy, according to correspondence accepted for publication in Annals of Allergy, Asthma and Immunology.¹

Neffy was first approved on August 9, 2024 for children at a weight of at least 66 lbs, then further expanded to include patients aged 4 years and older on March 5, 2025. ^2,3

Neffy real-world data for anaphylaxis

In the analysis, 545 patients who experienced anaphylaxis symptoms during oral food challenge or immunotherapy were treated with neffy by a healthcare provider. In all, 89.2% of patients treated with the epinephrine spray achieved symptom resolution with a single dose. This success rate mirrors findings from meta-analyses of epinephrine intramuscular injection or auto-injector, which report single-dose effectiveness in 88.9% of patients treated for food-induced anaphylaxis, according to ARS.

WATCH: RX Review: The role of needle-free epinephrine in pediatric allergy for 2025⁴

“These data reinforce existing findings and is the first large-scale report of real-world treatment outcomes with neffy during anaphylaxis events,” said Thomas B. Casale, MD, Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research at USF Health Morsani College of Medicine’s Division of Allergy and Immunology, in a statement. “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.”

Building on clinical trial data

The new evidence complements previously published clinical studies of neffy, including a phase 3 prospective trial of 15 patients undergoing oral food challenge. In that study, all patients responded to neffy without the need for a second dose to manage their initial reaction.5

Neffy is the first and only needle-free epinephrine product approved for use in the United States for the treatment of severe allergic reactions, including anaphylaxis. The nasal spray formulation was designed to overcome barriers to timely treatment, such as needle phobia and incorrect use of auto-injectors. ARS Pharmaceuticals emphasized that the pharmacokinetic and pharmacodynamic profiles of neffy align with those of established epinephrine injection products, supporting its clinical interchangeability.¹

“The real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection, building on the clinical studies conducted for FDA approval,” Casale added. “Neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”

Clinical implications

Anaphylaxis is a life-threatening systemic allergic reaction that requires immediate treatment with epinephrine. Historically, treatment has relied on intramuscular injection, typically delivered via auto-injector. However, challenges such as access, cost, and patient hesitation with needle-based products can delay administration.

References:

1. ARS Pharmaceuticals, Inc. ARS Pharmaceuticals announces real-world evidence of neffy® (epinephrine nasal spray) effectiveness in patients experiencing anaphylaxis symptoms. Press release. September 2025.
2. Fitch J. Neffy 1 mg now available for anaphylaxis in children aged 4 years and up. Contemporary Pediatrics. May 7. September 9, 2025. https://www.contemporarypediatrics.com/view/neffy-1-mg-now-available-for-anaphylaxis-is-pediatric-patients
3. Fitch J. FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older. Contemporary Pediatrics. March 6, 2025. Accessed September 9, 2025. https://www.contemporarypediatrics.com/view/fda-approves-neffy-for-anaphylaxis-in-children-aged-4-years-and-older
4. Schroer B, Kraft C, Traister R. RX Review: The role of needle-free epinephrine in pediatric allergy for 2025. Contemporary Pediatrics. March 12, 2025. Accessed September 9, 2025. https://www.contemporarypediatrics.com/view/rx-review-the-role-of-needle-free-epinephrine-in-pediatric-allergy-for-2025
5. Ebisawa M, Takahashi K, Takahashi KK, et al. Epinephrine nasal spray improves allergic symptoms in patients undergoing oral food challenge, phase 3 trial. J Allergy Clin Immunol. 2025; doi:10.1016/j.jaip.2025.06.038.