Epinephrine Nasal Spray Shows Rapid Symptom Relief in Pediatric Anaphylaxis Study

A phase 3 clinical trial found that neffy (epinephrine nasal spray) (ARS Pharmaceuticals, Inc.) provided faster symptom relief in children and adolescents experiencing anaphylaxis following oral food challenge compared with standard treatments.

Patients who received neffy as an initial treatment had significantly lower symptom scores within 10 minutes of administration, particularly for respiratory, gastrointestinal, and skin symptoms. The findings were presented at the 2025 American Academy of Allergy, Asthma, & Immunology Annual Meeting, February 28-March 3, in San Diego, CA.

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The study, conducted in Japan (jRCT2031230143), included 15 patients aged 6 to 17 years who experienced at least grade 2 anaphylaxis symptoms during an oral food challenge. A matched control group of 15 patients, aged 6 to 20 years, was prospectively selected based on clinical and laboratory data. Researchers analyzed symptom progression using a mixed-effects model for repeated measures.

All patients in the neffy group received the nasal spray as their first treatment, with some requiring additional medications such as antihistamines (n=6), beta-2 agonist inhalers (n=3), and steroids (n=1). Only one patient required intramuscular epinephrine for a biphasic reaction. In contrast, all patients in the control group received antihistamines, steroids (n=5), beta-2 inhalers (n=10), and intramuscular epinephrine (n=2).

Compared with the control group, the neffy group had significantly fewer skin symptoms at 15, 20, and 30 minutes posttreatment (P <.01). Respiratory symptoms improved more rapidly in the neffy group at 5, 10, and 15 minutes (P <.01), while gastrointestinal symptoms were lower at 5 and 10 minutes (P <.05) and 15 minutes (P <.01). Total symptom scores were also lower in the neffy group at 10 and 15 minutes (P <.05, P <.01, respectively).

These findings suggest that neffy may offer a faster, needle-free alternative for managing anaphylaxis in pediatric patients. "Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, said when the treatment was approved in August 2024.²

Takahashi K, Takahashi K, Yanagida N, et al. Superior efficacy of epinephrine nasals spray for the relief of symptoms following an oral food challenge. JACI. 2025;155(2) AB571. https://www.jacionline.org/pb-assets/Health%20Advance/journals/ymai/AAAAI_2025_March1-1738868846533.pdf

2. Halsey G. FDA Approves First Intranasal Epinephrine for Emergency Treatment of Allergic Reactions. Patient Care Online. August 9, 2024. https://www.patientcareonline.com/view/fda-approves-first-intranasal-epinephrine-for-emergency-treatment-of-allergic-reactions