A nasal spray to treat anaphylaxis can be used in more children than were part of the original approval.
The Food and Drug Administration (FDA) has approved neffy epinephrine nasal spray for emergency treatment of type I allergic reactions in children as young as 4 years who weigh at least 33 pounds. Last year, the treatment from ARS Pharmaceuticals was approved for children and adults weighing at least 66 pounds. Neffy is the first anaphylaxis treatment that does not require an injection.
Patients 4 years of age and older weighing 33-65 pounds can receive a 1 milligram (mg) dose of epinephrine nasal spray, while those weighing 66 pounds or more can receive a 2 mg dose. Patients whose symptoms worsen or do not improve may receive a second dose in the same nostril at least five minutes after the first dose. The smaller dosage sprays are expected to be available by the end of May, according to ARS. Full prescribing information is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697s001lbl.pdf.
In children, the most common adverse effects are nasal discomfort, upper respiratory tract congestion, dry throat, nasal dryness and tingling, according to the FDA.
Anaphylaxis can be caused by a variety of allergens such as certain foods, medications and insect stings. Patients may experience hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. It is considered a medical emergency.
When neffy was first approved, J. Andrew Bird, M.D., FAAP, chair of the AAP Section on Allergy and Immunology, said patients often are hesitant to give themselves an injection and he hoped the nasal spray option would “improve the likelihood that patients experiencing anaphylaxis will receive epinephrine when it’s needed.”
Resources
- Prescribing information for neffy epinephrine spray
- AAP clinical report Guidance on Completing a Written Allergy and Anaphylaxis Emergency Plan
- AAP clinical report Epinephrine for First-aid Management of Anaphylaxis
- Information from the FDA on food allergies
- Information for parents from HealthyChildren.org on anaphylaxis
