FDA approves nasal spray for emergency allergic reactions

The U.S. Food and Drug Administration approved neffy®, the first-ever nasal spray form of epinephrine, offering a needle-free alternative for treating severe, life-threatening allergic reactions, or anaphylaxis. This innovation may encourage timely use of life-saving medication, particularly for individuals who hesitate to use injections like EpiPens® and similar medicines, due to fear. At Private Health Management (PHM), our experts stay up to date on the latest developments in the treatment of many serious and complex conditions, including allergies and other immune disorders.

Epinephrine can halt life-threatening reactions
Anaphylaxis is a severe, life-threatening reaction that can occur after a person is exposed to an allergen, like a certain food or a bee sting. During anaphylaxis, the immune system releases a flood of chemicals that may cause the body to go into shock, and may narrow the airways, block breathing, and cause a sudden drop in blood pressure.

About 1 in 20 people in the U.S. have experienced anaphylaxis and about 225 people die from it each year.¹ The only lifesaving treatment is a dose of synthetic epinephrine, also known as adrenaline, which many people who are at risk already carry in the form of an epinephrine auto-injector (EpiPen®, Auvi-Q®).

In an emergency, epinephrine can be injected into the upper thigh. The medication enters the bloodstream, relaxes the muscles in the airway to improve breathing, raises blood pressure, and stops the release of histamine, the main chemical released by the body during an allergic response. But studies show that there are several barriers that prevent people from injecting the medication, including lack of proper training, stigma around carrying the devices, and fears about needles.^1,2

Neffy® provides needle-free dosing of epinephrine
The FDA approved neffy® for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds.³ The medication is administered as a single dose, into one nostril. A second dose in the same nostril, using a new nasal spray, may be given if there is no improvement in symptoms or symptoms worsen.⁶

Patients experiencing an anaphylactic episode should seek emergency medical assistance in case further treatment is required.

FDA approval was granted based on data from four clinical studies involving a total of 175 healthy adults who did not have anaphylaxis. The studies showed that a dose of neffy® spray was comparable to an epinephrine injection in elevating blood epinephrine levels, as well as increasing blood pressure and heart rate — both critical for effectively treating anaphylaxis.^3–5 The most common side effects included throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, gum pain, fatigue, sneezing, and nausea.

Patients with nasal conditions like polyps or prior surgery should consult their healthcare provider about using neffy®, as injectable epinephrine may be more suitable. Neffy® carries similar precautions as other epinephrine medications, especially for those with conditions like hyperthyroidism, kidney, or heart disease.

Patients at risk for anaphylaxis require thorough education, including the importance of always having their medication on hand and knowing how to use it correctly. The introduction of a non-injectable treatment for severe allergic reactions provides a more accessible option for many adults and children. At PHM, we provide education and support for patients to understand their treatment options.

References

1. ARS Pharmaceuticals Operations, Inc. Neffy-epinephrine spray. Prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1758142-a905-401d-8961-05829f51023a (2024).
2. Turner, P. J. et al. Fatal Anaphylaxis: Mortality Rate and Risk Factors. J Allergy Clin Immunol Pract 5, 1169–1178 (2017).
3. Kadivec, S. & Košnik, M. The Ability to Use Epinephrine Autoinjector in Patients Who Receive Prescription Immediately after Anaphylaxis. International Archives of Allergy and Immunology 182, 625–630 (2021).
4. Commissioner, O. of the. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis (2024).
5. Ellis, A. K. et al. Development of neffy, an Epinephrine Nasal Spray, for Severe Allergic Reactions. Pharmaceutics 16, 811 (2024).
6. Casale, T. B. et al. Adult pharmacokinetics of self-administration of epinephrine nasal spray 2.0 mg versus manual intramuscular epinephrine 0.3 mg by health care provider. The Journal of Allergy and Clinical Immunology: In Practice 12, 500-502.e1 (2024).