Neffy for patients with anaphylactic symptoms after oral food challenge


Thomas Casale, MD, discusses phase 3 data presented at the 2024 AAAAI Meeting in Washington DC, highlighting neffy's efficacy in pediatric patients at risk for anaphylaxis.

Thomas Casale, MD, professor of medicine, chief of Clinical and Translational Research, Allergy and Immunology, University of South Florida, spoke to Contemporary Pediatrics about a late-breaking poster session presented for neffy (epinephrine nasal spray; ARS Pharma) at the 2024 American Academy of Allergy, Asthma, & Immunology Annual Meeting (AAAAI) in Washington DC from February 23 to February 26, 2024.

Neffy, a potential needle-free option to treat type 1 allergic reactions, including anaphylaxis, was evaluated for safety and efficacy in a phase 3 study that included 15 children and adolescents aged 6 to 17 years in Japan who developed anaphylactic symptoms after oral food challenge (OFC).

Neffy was dosed when patients demonstrated respiratory, gastrointestinal, or circulatory symptoms that were grade 2 or higher, per the Severity Classification of Organ Symptoms by the Japanese Society of Allergology Anaphylaxis Guidelines 2022.

"We know that a lot of patients are reluctant to either inject themselves or inject their children with epinephrine because of needle phobia," said Casale. "Having alternatives is very important."

"The concept for this [study] was to determine whether or not neffy can immediately reverse the symptoms of an acute allergic reaction due to an oral food challenge."

According to results, 18 grade 2 symptoms were observed in the study, and no participants needed a second dose of epinephrine within 15 minutes post-dose of neffy.

"What we saw is that patients had a resolution of symptoms, rapidly," said Casale. "The time course of the resolution was very similar to what we would typically see with injectable epinephrine."

Thomas Casale, MD, discloses he is an advisor and consultant for Genentech and Novartis.


Ebisawa M, Lowenthal R, Tanimoto S, et al. Neffy, epinephrine nasal spray, demonstrates a positive efficacy and safety profile for the treatment of allergic reactions in pediatric patients at-risk of anaphylaxis: Phase 3 study results. Journal of Allergy and Clinical Immunology. doi:10.1016/j.jaci.2023.11.888

Related coverage:

Neffy epinephrine nasal spray demonstrates positive data in repeat dosing study

ARS Pharmaceuticals recently announced topline data for repeat doses of neffy, compared to repeat doses of epinephrine intramuscular (IM) injections with and without nasal allergen challenge (NAC) conditions in response to the FDA's request of a pharmacokinetic (PK) and pharmacodynamic (PD) study issued in a September 2023 Complete Response Letter (CRL).1

Click here for full repeat dose details.

FDA approves omalizumab to reduce allergic reactions in patients with 1 or more food allergies

Omalizumab (Xolair; Novartis and Genentech) has been approved by the FDA for the reduction of allergic reactions, including anaphylaxis, that can occur from accidental exposure to 1 or more foods in patients aged 1 year and older, according to a press release from Novartis.

Click here for more details and additional commentary Thomas Casale, MD.

Related Videos
Venous thromboembolism, Heparin-induced thrombocytopenia, and direct oral anticoagulants | Image credit: Contemporary Pediatrics
Scott Sicherer, MD, FAAP
Paul V. Williams, MD, FAAP
Related Content
© 2024 MJH Life Sciences

All rights reserved.