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.
Reference:
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
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