UMEM Educational Pearls

Background:

Epinephrine administration is a critical component of treating severe allergic reactions, and delayed administration is associated with increased morbidity and mortality. Epinephrine auto-injectors are the current standard of care and allow for rapid administration in all care settings, but compliance issues can limit their use. The most common reason patient’s site for failure to administer or delayed administration of auto-injectors is needle phobia (particularly with pediatric patients). This has led to interest in developing needle-free epinephrine delivery devices that are easy to administer.

New Drug Approval:

This August, the FDA approved an epinephrine nasal spray (brand name: Neffy) for use as emergency treatment for Type 1 allergic reactions, including life-threatening anaphylaxis. The approval was based on four studies, including 175 total patients, comparing epinephrine 2 mg nasal spray with an epinephrine 0.3 mg intramuscular injection in healthy adults and children. These studies showed similar blood concentrations of epinephrine between treatment arms through 60 minutes after administration. In addition, both treatment arms showed similar elevations in heart rate and systolic blood pressure.

• Who is it for?
  • Epinephrine 2 mg nasal spray is approved for all adult and pediatric patients who weight more than 30 kg (66 lbs).
• How is it supplied?
  • Epinephrine 2 mg nasal spray comes in single-use devices, as a unit-dose spray. This is the same device that is used for many other commercially available internasal products, including Narcan (naloxone) nasal spray.
• How it is given?
  • Epinephrine 2 mg nasal spray device should be fully inserted into one nostril pointing straight into the naris, and then the plunger should be depressed. If symptoms do not improve or worsen after the first dose, a second dose of epinephrine 2 mg nasal spray should be given into the same nostril.
• Common side effects?
  • The most common side effects are throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritis, sneezing, abdominal pain, gingival pain, oral hypoesthesia, nasal congestion, dizziness, nausea and vomiting. 

Bottom Line:

Epinephrine nasal spray is a newly approved option for the treatment of severe allergic reactions and anaphylaxis. While this approval was based on studies in healthy adults and children who did not currently have anaphylaxis, this medication may be worth considering for patients who have issues or concerns about using an injectable device to administer epinephrine.

References

1. Ellis AK, Casale TB, Kaliner M, et al. Development of neffy, an Epinephrine Nasal Spray, for Severe Allergic Reactions. Pharmaceutics. 2024;16(6):811. Published 2024 Jun 14. doi:10.3390/pharmaceutics16060811
2.  Tal Y, Ribak Y, Rubin L, et al. Fast Acting, Dry Powder, Needle-Free, Intranasal Epinephrine Spray: A Promising Future Treatment for Anaphylaxis. J Allergy Clin Immunol Pract. 2023;11(10):3047-3054. doi:10.1016/j.jaip.2023.06.044
3. Epinephrine spray [package insert]. San Diego, CA: ARS Pharma; 2024.