Epinephrine Nasal Spray Comparable to Injection in Real-World Data of Patients Experiencing Anaphylaxis

Woman using nasal drops | Image Credit: © Alliance - stock.adobe.com

San Diego-based ARS Pharmaceuticals announced on Sept. 8, 2025 that the first large-scale analysis demonstrating real-world, clinical evidence of treatment outcomes of its epinephrine nasal spray (Neffy) has been accepted for publication as correspondence in the Annals of Allergy, Asthma and Immunology (1). The nasal spray’s performance was observed in routine clinical practice in patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy.

How many patients have been successfully treated?

In a grouping of 545 patients, ARS Pharma said, nearly 9 out of 10 (89.2%) were successfully treated by a healthcare provider with a single dose of the spray (1). That response rate is consistent with meta-analyses that have reported 88.9% of patients successfully treated with one dose of epinephrine intramuscular injection or auto-injector.

The real-world data build upon prior clinical evidence—in particular, a prospective Phase III study in which, among 15 patients, none who were treated with the nasal spray required a second dose to treat the initial anaphylactic reaction (1).

Thomas B. Casale, MD, professor of Medicine and Pediatrics and chief of Clinical and Translational Research in the USF Health Morsani College of Medicine’s Division of Allergy and Immunology at the University of South Florida and a member of ARS Pharma’s scientific advisory board, said that the real-world data reinforce statistics that have previously been published.

“The finding that about 9 out of every 10 patients were successfully treated with a single dose of Neffy in more than 500 patients is essentially identical to the historic response rates observed with epinephrine injection,” Casale said in an ARS Pharma press release (1). “We believe these real-world outcomes data support the clinical interchangeability of Neffy and epinephrine injection, building on the clinical studies conducted for FDA approval that showed Neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”

Where has the nasal spray been approved so far?

FDA approved ARS Pharma’s epinephrine nasal spray, through fast track designation, for adults and children weighing at least 30 kilograms (66 pounds) in August 2024, making it the first non-injection emergency treatment for type 1 allergic reactions including anaphylaxis (2). That approval was based on cumulative results from four studies measuring epinephrine concentrations in 175 adults following administration of either the nasal spray or an injection, finding that blood concentrations were comparable between the two methods.

“This approval marks a watershed moment in addressing an unmet medical need for people with type 1 allergies—a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” Richard Lowenthal, ARS Pharma co-founder, president, and CEO, said at the time (2).

Another advancement for the ARS Pharma product, commercialized outside the United States, Australia, New Zealand, Japan and China by Denmark-based ALK under the name EURneffy, came in July 2025 when the Medicines and Healthcare products Regulatory Agency approved the nasal spray in 2-mg form for the same classification of patients in the United Kingdom as in the US (3). At that time, launch of the product in the UK was expected in the second half of 2025.

References

1. ARS Pharmaceuticals. Real-World Evidence Supports Clinical Effectiveness of Neffy (epinephrine nasal spray) in Patients Experiencing Anaphylaxis. Press Release. Sept. 8, 2025.
2. FDA. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. Press Release. Aug. 9, 2024.
3. ALK. EURneffy Approved as the First Needle-Free Anaphylaxis Treatment of Adults and Children in the UK. Press Release. July 18, 2025.