Epinephrine Nasal Spray Improves Allergic Symptoms in Patients Undergoing Oral Food Challenge, Phase 3 Trial

Rapid administration of epinephrine is the only approved first-line treatment for severe allergic reactions or anaphylaxis. Despite its well-established history of safety and efficacy, patients and caregivers have reported significant reluctance to administer epinephrine, largely owing to concerns about the injection. An epinephrine nasal spray (neffy) 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 patients with food allergy.

This was a phase 3 open-label study. Patients aged 6 to 17 years with food allergy (n = 15) were dosed with neffy after the onset of moderate (grade 2) OFC-induced anaphylaxis symptoms. Patients weighing 15 to less than 30 kg received neffy 1 mg, and those weighing 30 kg or more received neffy 2 mg.

All 15 patients exhibited at least one grade 2 anaphylaxis symptom after 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 45 minutes after neffy administration and was treated with intramuscular epinephrine. Median time to symptom resolution was 16 minutes. Adverse events observed in two or more patients that were not induced by the OFC included tremor (three patients; 20.0%) and nasal mucosal erythema (two 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.