Safety Solidified: Results of Oral Food Challenge Trials With Nasal Epinephrine Spray

EP: 1.Understanding Anaphylaxis: The Signs, Symptoms, and Burdens

EP: 2.Epinephrine First: The Proven First-Line Treatment for Anaphylaxis

EP: 3.Bridging the Barriers: What is Preventing Patients From Using Epinephrine

EP: 4.An Opportunity for Innovation: Rethinking Unmet Needs in Epinephrine Administration

EP: 5.Nasal Epinephrine Spray: Review of Clinical Trial Results

EP: 6.Immediate Impact: Nasal Epinephrine Spray After Allergen Challenge

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EP: 7.Safety Solidified: Results of Oral Food Challenge Trials With Nasal Epinephrine Spray

EP: 8.A Fit for Many: Storage, Shelf Life, and Ideal Patients

EP: 9.Transitioning to the Real-World: Expert Experiences with Nasal Epinephrine Spray

Efficacy in Nasal Congestion and Real-World Clinical Data

To address concerns about intranasal epinephrine effectiveness during allergic reactions with nasal congestion, researchers conducted studies using nasal allergen challenges to induce congestion before Neffy administration. Results showed comparable epinephrine blood concentrations between intranasal Neffy and intramuscular injection, even with significant nasal mucosal swelling. When comparing double-dose administrations, giving both Neffy doses in the same nostril produced higher epinephrine concentrations than alternating nostrils, likely due to Intravail's continued effect on mucosal permeability.

Pharmacodynamic studies demonstrated rapid receptor activation within the first minute after Neffy administration. Both systolic blood pressure and heart rate showed significant increases within one minute, indicating effective beta-adrenergic receptor stimulation. These vital sign changes were sustained over time and compared favorably to intramuscular epinephrine injection, confirming rapid onset of therapeutic effects.

Real-world clinical evidence comes from Japanese regulatory studies requiring actual anaphylaxis treatment data. Fifteen pediatric patients (ages 6-17) undergoing oral food challenges received Neffy for grade 2 anaphylaxis symptoms including gastrointestinal, respiratory, and cardiovascular manifestations. All patients showed symptom resolution with median time of 16 minutes, and none required second epinephrine doses during the observation period. Only mild, self-limited adverse events occurred, primarily tremor and nasal mucosal erythema.