FDA Approves First Intranasal Epinephrine for Emergency Treatment of Allergic Reactions

The FDA announced today approval of neffy (epinephrine nasal spray) for emergency treatment of type 1 allergic reactions, including anaphylaxis, the most serious and life-threatening response to an allergen. The approval, granted to ARS Pharma, is for use of the nasal spray in adults and children who weigh at least 66 pounds, according to an agency statement.¹

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The intranasal application is the first alternative to epinephrine delivered via manual syringe, the reference-listed drug and historical basis for efficacy for all other epinephrine products, according to the FDA.¹ neffy has demonstrated pharmacokinetic (PK) equivalence to epinephrine products administered via autoinjector and prefilled syringe. In a repeat dosing study neffy delivered a PK and pharmacodynamic (PD) profile greater than or similar to that of intramuscular epinephrine after extreme nasal challenge.²

“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,” Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research.¹

The FDA's decision is based on 4 clinical studies that included 175 healthy adults who did not have anaphylaxis. The findings showed comparable epinephrine blood concentrations between neffy or approved epinephrine injection products, FDA said. Further, analysis of these data showed that PD surrogate marker responses for efficacy in anaphylaxis (systolic blood pressure and heart rate) correlated well with PK exposures. In a study of children who weighed more than 66 pounds, epinephrine levels achieved with neffy were similar to those seen among adults, the agency reported.¹

Neffy is administered via single dose nasal spray into 1 nostril. If there is no improvement or symptoms worsen, a caregiver may give a second dose, using a new unit of the nasal spray, in the same nostril. The same repeat administration pattern is recommended with injectable epinephrine. The FDA advises that emergency medical assistance may still be required for close monitoring of an anaphylactic episode and if additional treatment is needed to stabilize the individual.¹

Neffy prescribing information warns that nasal conditions such as polyps or a history of nasal surgery may impair intranasal absorption. For those individuals, ARS Pharma recommends consultation with a health care professional to decide whether an injectable epinephrine product may be more appropriate, according to the FDA news release.¹ The neffy label also includes precautions about use of the medication by people with known allergic reactions associated with sulfite.

“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need,” FDA's Stone said.¹

Neffy will be available in the US within 8 weeks of todays approval for individuals weighing 30 kg or more, according to ARS Pharma.² The company also stated it has plans to file a supplemental new drug application with the FDA for neffy use in children who weigh 15 kg to less than 30 kg by the end of the third quarter this year.

References

1. FDA approves first nasal spray for treatment of anaphylaxis. News release. FDA. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis
2. Halsey G. Neffy Generates Favorable PK/PD Data Under Nasal Allergen Challenge in Repeat Dosing Study Requested by FDA. Patient Care. February 26, 2024. https://www.patientcareonline.com/view/neffy-generates-favorable-pk-pd-data-under-nasal-allergen-challenge-in-repeat-dosing-study-requested-by-fda