FDA Approves Epinephrine Nasal Spray for Emergency Treatment of Allergic Reactions

On August 9, 2024, the US Food and Drug Administration (FDA) announced its approval of ‘neffy,’ an epinephrine nasal spray designed for emergency treatment of severe allergic reactions, such as life-threatening anaphylaxis, in adults and children.¹

The milestone approval allows for the first alternative option to injectable epinephrine, in the form of such products as the EpiPen. The spray is administered in a single-dose into 1 nostril, though a second dose may be administered in the same nostril if symptoms do not improve.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy and critical Care at the FDA’s Center for Drug Evaluation and Research, said in a statement. “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections.”

In September 2023, FDA officials had chosen not to approve of neffy, representing what was viewed as a setback for patients suffering from severe allergies with no viable alternatives to injectable epinephrine.²

Anaphylaxis is a particularly severe and potentially fatal response to allergens that involves multiple body systems, requiring immediate medical attention. Some of the more common triggers for such a reaction include medications, certain foods, and insect stings, with symptoms such as swelling, hives, vomiting, itching, breathing issues, and loss of consciousness within minutes of exposure.

The only treatment available that can potentially reverse such a reaction is epinephrine. The approval of neffy was supported by 4 clinical trials evaluating a total of 175 healthy adult subjects. The studies compared the epinephrine levels in the blood of these subjects following administration of the nasal spray and other current injectable epinephrine products.

Neffy was noted as having shown similar concentrations of epinephrine in the blood as the injectable options. The studies also concluded that comparable increases in subjects’ blood pressure and heart rates were noted—2 key impacts of epinephrine in treating anaphylaxis.

Among children weighing more than 66 pounds, the epinephrine levels achieved with the nasal spray in 1 study were shown to be similar to those seen among adult patients. Though the spray may be easily implemented, the FDA announcement notes that patients may still require emergency medical care for the purposes of monitoring the anaphylactic episode.

The announcement regarding neffy’s approval also included a warning for those with certain nasal conditions, such as a history of nasal surgery or nasal polyps. It notes that these might impact the absorption of the treatment, therefore consultation with health care providers may be needed.

The announcement also informs readers about neffy’s warnings and precautions related to its utilization in patients known to have specific coexisting conditions and allergies related to sulfite. Patients must weigh at least 30 kilograms (approximately 66 pounds) if they wish to use the treatment.

The availabity of neffy is expected in the US within 8 weeks of the FDA's decision. Those interested in this treatment option may visit the website www.neffy.com to register for product updates, 1 of which would be when telemedicine services may become available.³

A supplemental NDA (sNDA) application for the nasal spray is planned by ARS Pharma for children who weigh 15 to <30 kg, and the sNDA is expected by the end of Q3 in 2024. The product's shelf life is noted as 30 months, allowing for temperature exposure up to 122°F (50°C). Neffy can also be thawed and then adminstered if accidentally frozen.

“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine," Thomas B. Casale, MD, professor of Medicine and Pediatrics and chief of Clinical and Translational Research at the University of South Florida, said in a statement. "In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment."³

References

1. ^{Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.}
2. ^{Smith T. Edwin H. Kim, MD: Responding to FDA Decision Not to Approve ‘Neffy’ Treatment. HCPLive. September 26, 2023. https://www.hcplive.com/view/edwin-h-kim-md-responding-to-fda-decision-not-to-approve-neffy-treatment. Date accessed: August 9, 2024.}
3. ^{ARS Pharmaceuticals. Ars Pharmaceuticals receives FDA approval of Neffy® (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis. ARS Pharmaceuticals. August 9, 2024. Accessed August 9, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine.}