Drug Watch: A Nasal Epinephrine

Educational Objectives

Summary

Drug Watch: Newly Approved Intranasal Epinephrine

On August 9, 2024, the U.S. FDA approved a 2-mg epinephrine nasal spray (trade name “neffy”; https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis) for the emergency treatment of type 1 allergic reactions in adults and children (weight, ≥30 kg [≥66 lbs]).

Background

Epinephrine is the only agent for anaphylaxis that attenuates life-threatening symptoms. Until now, intramuscular administration in the lateral thigh has been the only option, and this process has discouraged some needle-phobic patients or parents of young children. But now, patients will have the option of a nasal spray.

Studies that led to U.S. FDA approval

In a randomized crossover trial in The Journal of Allergy and Clinical Immunology (https://doi.org/10.1016/j.jaci.2023.08.007), 59 healthy adults were given single manual injections of epinephrine (0.3 mg via syringe), nasal epinephrine (2 mg; the FDA-approved dose for neffy) or epinephrine via auto injector (EpiPen; 0.3 mg). The maximum plasma concentrations for manual injection, intranasal 2-mg dose (neffy), and EpiPen were 339, 481, and 753 pg/mL, and maximum increases in systolic blood pressure were 11.9, 23.6, and 18.3 mm Hg, respectively. Confirmatory pharmacokinetic and pharmacodynamic studies were done in people with histories of type 1 allergy and in people with allergic rhinitis or upper respiratory infection to ensure adequate nasal absorption under those conditions (https://doi.org/10.3390/pharmaceutics16060811).

Selected points from the official neffy prescribing information

• Patients should have access to two neffy devices. A second device can be used in the same nostril after 5 minutes, if needed.

• Epinephrine can precipitate angina or arrhythmias.

• Nasal abnormalities, such as polyps, can affect absorption.

• The only currently available dose is 2 mg, which is approved for adults and children who weigh ≥30 kg (FDA neffy label information; https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214697s000lbl.pdf). The manufacturer plans to file for a lower dose for children who weigh 15 to 30 kg. (For reference, intramuscular epinephrine is dosed at 0.01 mg/kg [up to 0.5 mg] and comes in 0.15 mg and 0.3 mg auto-injectors.)

Patients are already asking me when neffy will be available in pharmacies. (The answer is 8 weeks postapproval, per the manufacturer.) I think neffy will encourage patients to use epinephrine earlier, which can stop allergic reactions before they become life threatening. I frequently hear “I didn’t use my EpiPen because I didn’t want to go to the emergency department (ED).” I tell patients that the best way to avoid going to the ED is to use epinephrine early. During the COVID‑19 pandemic (when we tried to minimize ED visits), we learned that patients who self-administer epinephrine don’t necessarily need to seek medical attention, unless they have an inadequate response to the first dose, have a secondary or biphasic reaction, or have severe airway or cardiovascular compromise (https://doi.org/10.1016/j.anai.2023.01.015). For patients without insurance or with a high deductible, neffy’s manufacturer will offer a cash price of US$199 for two doses. Two generic auto injectors can be purchased through GoodRx for as low as $111.

David J. Amrol, MD

Readings

Disclosures

Acknowledgements

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0.00 CE contact hours.

Lecture ID:

JW351810

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.

More Details - Certification & Accreditation