On August 9th, 2024 the U.S. FDA approved a new nasal epinephrine formulation. A first of its kind, Neffy is a nasal epinephrine preparation approved for the treatment of anaphylaxis. The novel formulation allows for delivery of a 2mg dose intra-nasally for rapid treatment of Type I allergic reactions. It is the first alternative to injectable epinephrine to be approved.
The spray is approved for adults and children weighing at least 30kg (66 lbs). It is delivered as a single spray in one nostril. A second dose (new device in the same nostril) may be given if there is no improvement 5 minutes after the first dose. The box will contain two nasal sprays.
According to the American Academy of Allergy Asthma & Immunology, there are almost 500,000 visits annually to U.S. emergency departments for anaphylaxis. Other sources note that only 46% of anaphylaxis patients receive epinephrine.
The manufacturer of Neffy, ARS Pharmaceuticals, hopes to have the product available in the U.S. in 8 weeks. ARS also plans to apply for approval of a 1mg nasal epinephrine spray for children weighing less than 30kg.
According to ARS Pharmaceuticals, Neffy has a shelf life of 30 months and can be exposed to temperatures as high as 122°F (50°C). The spray is anticipated to cost $25 for patients with commercial insurance and $199 without insurance.
For more information on the ED evaluation and treatment of anaphylaxis:
- Management of Allergic Reactions and Anaphylaxis in the Emergency Department (Pharmacology CME)
- Evidence-Based Management of Angioedema in Urgent Care (Pharmacology CME)
Sam Ashoo, MD, FACEP, is board certified in emergency medicine and clinical informatics. He serves as EB Medicine’s editor-in-chief of interactive clinical pathways and FOAMEd blog, and host of EB Medicine’s EMplify podcast. Follow him below for more…
