U.S. Food and Drug Administration (FDA) Approves the First Needle-Free Epinephrine for Anaphylaxis (2024)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. Who the Approval Covers
3. The Reasons the U.S. Food and Drug Administration Gave
4. Anaphylaxis as the U.S. Food and Drug Administration 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 U.S. Food and Drug Administration Steps
10. Dates and Status as of 11 October 2026
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the U.S. Food and Drug Administration Did

The U.S. Food and Drug Administration news release “U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s news release; the 2023 Federal Register notice described below identifies the application as new drug application 214697. The release also states that the U.S. Food and Drug Administration granted the application Fast Track designation. The U.S. Food and Drug Administration 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.”

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2. Who the Approval Covers

According to the U.S. Food and Drug Administration, 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 U.S. Food and Drug Administration’s release gives no approval for that group.

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3. The Reasons the U.S. Food and Drug Administration Gave

The release quotes the Associate Director of the Division of Pulmonology, Allergy and Critical Care in the U.S. Food and Drug Administration’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 U.S. Food and Drug Administration’s stated rationale, in short, is access: a form of epinephrine that some people may be more willing to use quickly than an injection.

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4. Anaphylaxis as the U.S. Food and Drug Administration Describes It

The U.S. Food and Drug Administration’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.”

• Common triggers named by the U.S. Food and Drug Administration: certain foods, medications and insect stings.
• Timing: symptoms usually occur within minutes of exposure.
• Symptoms listed by the U.S. Food and Drug Administration include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness.
• Treatment: the U.S. Food and Drug Administration states that “epinephrine is the only life-saving treatment for anaphylaxis” and that it had previously only been available for patients as an injection.

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.

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5. The Studies Behind the Approval

The U.S. Food and Drug Administration 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 U.S. Food and Drug Administration reports:

• Blood levels: the studies “showed comparable epinephrine blood concentrations” between the nasal spray and approved epinephrine injection products.
• Body effects: the spray “demonstrated similar increases in blood pressure and heart rate” as the injection products. The U.S. Food and Drug Administration calls these “two critical effects of epinephrine in the treatment of anaphylaxis.”
• Children: a study in children weighing more than 66 pounds showed that their epinephrine blood concentrations were similar to those of adults who received the spray.

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.

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6. How the Spray Is Given

As described in the U.S. Food and Drug Administration’s release:

• It is “a single dose nasal spray administered into one nostril.”
• As with epinephrine injection products, a second dose, using a new nasal spray device in the same nostril, may be given if symptoms do not improve or if they get worse.
• The U.S. Food and Drug Administration adds that patients may need emergency medical help for close monitoring of the anaphylactic episode and in case further treatment is required.

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7. Warnings and Common Side Effects

Nasal conditions. The U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration:

• throat irritation, nasal discomfort, runny nose (rhinorrhea), nasal congestion and sneezing
• tingling nose (intranasal paresthesia), itchiness inside the nose (nasal pruritus) and a general tingling sensation (paresthesia)
• headache, dizziness, feeling jittery, tremor and fatigue
• numbness in the mouth (oral hypoesthesia) and gum (gingival) pain
• abdominal pain, nausea and vomiting

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8. What the Approval Does Not Do

• It does not cover children under 30 kilograms. The 2024 approval is limited to adults and children weighing at least 30 kilograms (about 66 pounds).
• It does not rest on trials during anaphylaxis. The four adult studies were in healthy adults without anaphylaxis, and the evidence the U.S. Food and Drug Administration describes is blood epinephrine levels plus blood-pressure and heart-rate responses compared with approved injections.
• It does not remove injectable epinephrine. The approval adds a new dosage form; the U.S. Food and Drug Administration’s own warning points people with nasal polyps or past nasal surgery toward an injectable product.
• It does not replace emergency care. The U.S. Food and Drug Administration’s release states that patients may need emergency medical assistance for monitoring and further treatment.
• It is not a rule. It is the approval of one drug application, announced in a news release rather than through Federal Register rulemaking.

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9. Earlier and Later U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee for 11 May 2023. The notice describes the committee’s general function as providing “advice and recommendations to U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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 a U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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.

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10. Dates and Status as of 11 October 2026

• 29 March 2023: Federal Register notice of the advisory committee meeting on the application (88 FR 18555).
• 11 May 2023: date set for the Pulmonary-Allergy Drugs Advisory Committee meeting.
• 9 August 2024: U.S. Food and Drug Administration approves epinephrine nasal spray for adults and children of at least 30 kilograms.
• 24 November 2025: Federal Register notice of the U.S. Food and Drug Administration public workshop on access to epinephrine (90 FR 52958).
• 16 December 2025: public workshop held; comment period closed 16 January 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.

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11. Primary Documents

1. U.S. Food and Drug Administration (2024). U.S. Food and Drug Administration Approves First Nasal Spray for Treatment of Anaphylaxis. U.S. Food and Drug Administration 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, U.S. Department of Health and Human Services (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, U.S. Department of Health and Human Services (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

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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

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Connections

• U.S. Food and Drug Administration Actions of 2024
• U.S. Food and Drug Administration and Regulation
• Anaphylaxis
• Food Allergy
• Drug Allergy
• Allergies
• Pain and Allergy
• Anaphylaxis and Epinephrine (Animation)
• John Jacob Abel: Epinephrine and Crystalline Insulin
• Donanemab for Early Alzheimer’s (2024)
• Xanomeline-Trospium for Schizophrenia (2024)
• First MASH Liver Drug (2024)
• Over-the-Counter Glucose Monitor (2024)

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