Rapid administration of epinephrine is the only approved first-line treatment for severe allergic reactions/anaphylaxis. Despite its well-established history of safety and efficacy, patients and caregivers have reported significant reluctance to administer epinephrine, largely due to concerns about the injection. An epinephrine nasal spray was recently approved as the first needle-free epinephrine option for the treatment of severe allergic reactions.

This study was conducted to assess neffy’s efficacy for the treatment of oral food challenge (OFC)-induced anaphylaxis symptoms in pediatric food allergy patients.

This was a Phase 3 open label study. Food allergy patients aged 6 to 17 (N = 15) were dosed with neffy following onset of moderate (Grade 2) OFC-induced anaphylaxis symptoms. Patients 15 – <30 kg received neffy 1 mg, and patients ≥30 kg received neffy 2 mg.

All 15 patients exhibited at least one Grade 2 anaphylaxis symptom following an OFC. No patients required a second dose of epinephrine for treatment of the initial reaction; however, one patient developed a biphasic reaction 2 hours and 45 minutes following neffy administration and was treated with intramuscular epinephrine. The median time to symptom resolution was 16 minutes. The adverse events observed in ≥2 patients that were not induced by the OFC included tremor (3 patients, 20.0%) and nasal mucosal erythema (2 patients, 13.3%).

neffy successfully treated OFC-induced anaphylaxis symptoms. The availability of a needle-free epinephrine delivery device may reduce dosing hesitancy, particularly in patients who are fearful of injections.