By William Elliott, MD, FACP, and James Chan, PharmD, PhD
The U.S. Food and Drug Administration has approved epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis. It was granted a fast-track designation and will be distributed by ARS Pharmaceuticals as Neffy.1
Indications
Epinephrine nasal spray is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients who weigh 30 kg or more.2
Dosage
The recommended dose is one spray administered into one nostril.2 A second dose may be administered starting five minutes after the first dose in absence of clinical improvement or if symptoms worsen after initial treatment. It is recommended that patients be prescribed or have access to two nasal sprays at all times. Epinephrine nasal spray is available as 2 mg/0.1 mL per unit-dose spray.
Potential Advantages
The nasal spray provides a needle-free, pain-free option for the treatment of severe allergic reactions, including anaphylaxis. Dodecylmaltoside, a proprietary absorption-enhancing agent, is used to improve the bioavailability of epinephrine.3 This allows the dose of epinephrine to remain as low as possible while still maintaining effectiveness.3
Potential Disadvantages
Epinephrine nasal spray contains sodium metabisulfite, which may trigger allergic-type reaction in certain susceptible individuals.2 The absorption of epinephrine may be affected by underlying structural and anatomical nasal conditions.2 The most frequent adverse reactions (> 5%) are throat irritation, headache, nasal discomfort, feeling jittery, tremor, and rhinorrhea.2
Comments
The approval of epinephrine nasal spray was based on four studies that compared epinephrine concentrations and pharmacodynamic measures, systolic blood pressure (SBP), and pulse rate (PR) following one and two doses of the nasal spray, intramuscular epinephrine (0.3 mg), and the auto-injector.2 The pharmacokinetic profile was within the range of currently approved epinephrine injectable products, and the pharmacodynamic profile was comparable or better.3 Epinephrine levels were higher with the auto-injector over the first 10 minutes but generally similar to intramuscular epinephrine and auto-injector after 20-30 minutes post-dose.2
A similar pattern was observed with two doses given 10 minutes apart among the three formulations. Median SBP/PR were higher with the nasal formulation compared to both injection formulations. A similar pattern was observed in patients with type I allergies without anaphylaxis. In subjects with nasal allergen challenge (NAC)-induced rhinitis, patients administered a single dose of nasal epinephrine showed increased absorption and with more rapid clearance compared to those without NAC.
However, there appears to be sufficient epinephrine exposure in the first five to 15 minutes compared to intramuscular epinephrine.3 After two doses, the geometric mean epinephrine levels in pediatric patients (weighing ≥ 30 kg and aged 8-17 years) with type I allergies without anaphylaxis were numerically higher than that of healthy adults at the same dose.2
Clinical Implications
Approximately one in 20 Americans have experienced a severe allergic reaction (i.e., anaphylaxis).4 The most common triggers are food, medication, and insect stings. The primary treatment is epinephrine, which requires injection by needle.
An epinephrine nasal spray provides an attractive alternative to the injectable formulations. It may remove the barrier for some patients who are concerned about needles and pain associated with administration. The cost for epinephrine nasal spray is $710 for two units.
References
- U.S. Food and Drug Administration. FDA approves first nasal spray for treatment of anaphylaxis. Published Aug. 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis
- U.S. Food and Drug Administration. Neffy Prescribing Information. ARS Pharmaceuticals Operations, Inc. August 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214697s000lbl.pdf
- Ellis AK, Casale TB, Kaliner M, et al. Development of Neffy, an epinephrine nasal spray, for severe allergic reactions. Pharmaceutics 2024;16:811.
- Allergy & Asthma Network. Anaphylaxis statistics. https://allergyasthmanetwork.org/anaphylaxis/anaphylaxis-statistics/
The U.S. Food and Drug Administration has approved epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis. It was granted a fast-track designation and will be distributed by ARS Pharmaceuticals as Neffy.
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