The indication for adrenaline nasal spray Neffy has been expanded (by the US FDA) to include children four years of age and older who weigh 15 to less than 30 kg.
Earlier on 9 August 2025, Neffy was approved for the emergency treatment of type 1 allergic reactions, including those that are life-threatening anaphylaxis, in adults and children who weigh at least 30 kg (66 pounds). It is the first FDA-approved nasal spray to treat anaphylaxis and the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.
On 28 June 2024, Eurneffy, the first nasal adrenaline spray for emergency treatment against allergic reactions (anaphylaxis) was granted marketing authorisation in the European Union (EU) by the European Medicine Agency (EMA).
The adrenaline nasal spray for emergency treatment against allergic reactions (anaphylaxis) is awaiting approval in the United Kingdon and Canada.
The approval of adrenaline nasal spray for emergency treatment against allergic reactions provides an alternative route of administration of adrenaline to those (especially children) averse to injections and are faced with a life-threatening situation of anaphylaxis.
Adrenaline (also known as epinephrine) is the only life-saving treatment for anaphylaxis. It is available so far only as an injection usually administered through intramuscular (IM) or intravenous (IV) route. Neffy/Eurneffy is the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. It is a single dose nasal spray administered into one nostril. A second dose (using a new nasal spray to the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitoring.
Anaphylaxis is considered a medical emergency. It is a severe, life-threatening allergic reaction that typically involves multiple parts of the body. Certain foods, medications and insect stings are common allergens that can induce anaphylaxis. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness.
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References:
- FDA News release -FDA Roundup: 7 March 2025. Available at https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025
- EMA. News – First nasal adrenaline spray for emergency treatment against allergic reactions. Posted 28 June 2024. Available at https://www.ema.europa.eu/en/news/first-nasal-adrenaline-spray-emergency-treatment-against-allergic-reactions
- ARS Pharmaceuticals Files for Approval of neffy® in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S. Posted 6 January 2025. Available at https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-files-approval-neffyr-canada-and-united
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Related article
- Epinephrine (or Adrenaline) Nasal Spray for Treatment of Anaphylaxis (10 August 2024)
- A New Easy Treatment for Peanut Allergy (15 November 2018)
- Tricking the Body: a New Preventive Way to Tackle Allergies (15 April 2018)
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