FDA Approves the First Needle-Free Epinephrine for Anaphylaxis (2024)

On Friday 9 August 2024 the U.S. Food and Drug Administration approved an epinephrine nasal spray for the emergency treatment of severe allergic reactions, including anaphylaxis, in adults and children who weigh at least 30 kilograms (about 66 pounds). In the FDA’s words, the approval provides “the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.” Until then, the agency noted, epinephrine had only been available to patients as an injection. The condition itself is described on the site’s Anaphylaxis page.

This page reports what the FDA’s announcement says: who the approval covers, the reasons the agency gave, the studies the approval rests on, how the spray is given, the warnings and common side effects the FDA listed, what the approval does not do, the earlier and later FDA steps on the same subject, its status as of 11 October 2026, and published research on needle-free epinephrine. The product is named here only by its generic description, epinephrine nasal spray.

Table of Contents

  1. What the FDA Did
  2. Who the Approval Covers
  3. The Reasons the FDA Gave
  4. Anaphylaxis as the FDA Describes It
  5. The Studies Behind the Approval
  6. How the Spray Is Given
  7. Warnings and Common Side Effects
  8. What the Approval Does Not Do
  9. Earlier and Later FDA Steps
  10. Dates and Status as of 11 October 2026
  11. Primary Documents
  12. Key Research Papers
  13. Connections

1. What the FDA Did

The FDA news release “FDA Approves First Nasal Spray for Treatment of Anaphylaxis” is dated 9 August 2024. It states that the agency approved an epinephrine nasal spray “for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis).”

This was a drug approval, announced in the FDA’s news release; the 2023 Federal Register notice described below identifies the application as new drug application 214697. The release also states that the FDA granted the application Fast Track designation. The FDA describes Fast Track as “a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”

Back to Table of Contents

2. Who the Approval Covers

According to the FDA, the approval covers “adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).” The approved use is emergency treatment of Type I allergic reactions, including anaphylaxis.

The weight limit means the 2024 approval does not include smaller children below 30 kilograms. The FDA’s release gives no approval for that group.

Back to Table of Contents

3. The Reasons the FDA Gave

The release quotes the Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research:

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”

The same official called the spray “an important treatment option” that “addresses an unmet need.” The FDA’s stated rationale, in short, is access: a form of epinephrine that some people may be more willing to use quickly than an injection.

Back to Table of Contents

4. Anaphylaxis as the FDA Describes It

The FDA’s release gives this background. Allergic reactions happen when a person’s immune system reacts abnormally to a substance that normally does not cause symptoms. Anaphylaxis is “a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency.”

Food-triggered reactions are covered on the site’s Food Allergy page, and an interactive animation of how epinephrine acts during anaphylaxis is on the Biology page.

Back to Table of Contents

5. The Studies Behind the Approval

The FDA states that the approval “is based on four studies in 175 healthy adults, without anaphylaxis.” These studies measured how much epinephrine reached the blood after the nasal spray and after approved epinephrine injection products. The FDA reports:

Studies like these are called pharmacokinetic studies (how much of a drug gets into the blood, and how fast) and pharmacodynamic studies (what the drug does to the body, here blood pressure and heart rate). The approval rests on these measurements rather than on trials in people having an anaphylactic reaction.

Back to Table of Contents

6. How the Spray Is Given

As described in the FDA’s release:

Back to Table of Contents

7. Warnings and Common Side Effects

Nasal conditions. The FDA states that the product “comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption.” The warning, as the FDA reports it, says patients with these conditions “should consult with a health care professional to consider use of an injectable epinephrine product.”

Other warnings. The product also carries warnings and precautions about use of epinephrine by people with certain coexisting conditions, and about allergic reactions associated with sulfite.

Most common side effects listed by the FDA:

Back to Table of Contents

8. What the Approval Does Not Do

Back to Table of Contents

9. Earlier and Later FDA Steps

Before the approval (2023). A Federal Register notice published Wednesday 29 March 2023 (88 FR 18555, FR Doc. 2023-06481, docket FDA-2023-N-0984) announced a virtual meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee for 11 May 2023. The notice describes the committee’s general function as providing “advice and recommendations to FDA on regulatory issues.” The notice states that the committee would discuss new drug application 214697, for epinephrine nasal spray, for the proposed use of “emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children ≥30 kilograms.” That is the same use and weight limit the FDA approved in August 2024. The notice opened a public docket for comments.

After the approval (2025). A Federal Register notice published Monday 24 November 2025 (90 FR 52958, FR Doc. 2025-20658, docket FDA-2025-N-2976) announced an FDA public workshop, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine,” held on 16 December 2025, with written comments accepted until 16 January 2026. Its stated purpose was “to initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality.” The notice’s background states that anaphylaxis has “a lifetime prevalence in the United States of up to 5 percent” and results in “approximately 200 deaths annually,” and it lists barriers the FDA identifies: patients prescribed epinephrine may not have it with them, may choose not to use it because of “knowledge gaps, fear, stigma, misperceptions, or discomfort,” or may use it incorrectly. It also names institutional, cost, rural-access and prescription barriers. The workshop notice is a request for discussion; it does not change the 2024 approval.

Back to Table of Contents

10. Dates and Status as of 11 October 2026

Legal status: final. The approval took effect on 9 August 2024. A check of the Federal Register through 11 October 2026 found no document withdrawing, suspending or otherwise changing this approval.

Back to Table of Contents

11. Primary Documents

  1. U.S. Food and Drug Administration (2024). FDA Approves First Nasal Spray for Treatment of Anaphylaxis. FDA News Release, 9 August 2024 — fda.gov press announcement
  2. U.S. Food and Drug Administration. Fast Track (patient information page on expedited programs) — fda.gov Fast Track
  3. Food and Drug Administration, HHS (2023). Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments. Federal Register 88:18555, 29 March 2023. Docket No. FDA-2023-N-0984 — FR Doc. 2023-06481
  4. Food and Drug Administration, HHS (2025). Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments. Federal Register 90:52958, 24 November 2025. Docket No. FDA-2025-N-2976 — FR Doc. 2025-20658

Back to Table of Contents

Key Research Papers

  1. Tanimoto S, Kaliner M, Lockey RF, Ebisawa M, Koplowitz LP, Koplowitz B, Lowenthal R (2023). Pharmacokinetic and pharmacodynamic comparison of epinephrine, administered intranasally and intramuscularly: An integrated analysis. Annals of Allergy, Asthma & Immunology 130(4):508-514.e1 — PubMed PMID: 36334720
  2. Greenhawt M, Lieberman J, Blaiss M, Bernstein DI, Oppenheimer J, DuBuske L, Fleischer D, Dworaczyk DA (2024). Pharmacokinetic and Pharmacodynamic Profile of Epinephrine Nasal Spray Versus Intramuscular Epinephrine Autoinjector in Healthy Adults. Journal of Allergy and Clinical Immunology: In Practice 12(12):3274-3282.e2 — PubMed PMID: 39395775
  3. Golden DBK, Wang J, Waserman S, Akin C, Campbell RL, Ellis AK, Greenhawt M, Lang DM, et al. (2024). Anaphylaxis: A 2023 practice parameter update. Annals of Allergy, Asthma & Immunology 132(2):124-176 — PubMed PMID: 38108678
  4. Lieberman JA, Greenhawt M (2025). Advances in the treatment of anaphylaxis: intranasal and sublingual versus intramuscular epinephrine. Current Opinion in Allergy and Clinical Immunology 25(5):309-314 — PubMed PMID: 40643429
  5. Crescioli G, Giovannini M, Pessina B, Barni S, Muraro A, Vannacci A, Mori F (2025). Epinephrine nasal spray for the treatment of anaphylaxis: perspectives in pediatrics. Current Opinion in Allergy and Clinical Immunology 25(6):511-517 — PubMed PMID: 40971222
  6. Bernstein DI, Blaiss M, Dellon ES, Rance K (2025). Benefits of Epinephrine for Anaphylaxis Outweigh Potential Harm-A Safety Review. Journal of Allergy and Clinical Immunology: In Practice 13(12):3188-3194 — PubMed PMID: 40254271
  7. Narchi H, Elghoudi A, Al Dhaheri K (2022). Barriers and challenges affecting parents’ use of adrenaline auto-injector in children with anaphylaxis. World Journal of Clinical Pediatrics 11(2):151-159 — PubMed PMID: 35433301
  8. Dribin TE, Sobolewski B, Campbell RL, Turner PJ, Garvey LH, Soar J, Wang J, Shaker MS, et al. (2026). Anaphylaxis Clinical Care Pathway: Incorporating Intranasal Epinephrine (Adrenaline). Journal of Allergy and Clinical Immunology: In Practice 14(10):2254-2261 — PubMed PMID: 42447993

PubMed Topic Searches

  1. PubMed: intranasal epinephrine and anaphylaxis
  2. PubMed: epinephrine nasal spray pharmacokinetics
  3. PubMed: barriers to epinephrine use in anaphylaxis

Back to Table of Contents

Connections

Back to Table of Contents