ARS Pharma Reports Real-World Evidence Supporting neffy® Nasal Spray For Anaphylaxis Treatment

ARS Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on protecting patients at risk of anaphylaxis, announced new real-world evidence supporting the clinical performance of neffy® (epinephrine nasal spray). The analysis, accepted for publication in the Annals of Allergy, Asthma and Immunology, evaluated patient outcomes when neffy was administered during oral food challenge (OFC) and allergen immunotherapy (AIT) in routine clinical practice.

In a cohort of 545 patients experiencing anaphylaxis symptoms, 89.2% were successfully treated with a single dose of neffy by healthcare providers. This real-world effectiveness rate closely mirrors results from meta-analyses of epinephrine delivered via intramuscular injection or auto-injector, which show a treatment success rate of 88.9% for food-induced anaphylaxis. These findings reinforce neffy’s potential as a needle-free alternative with comparable clinical outcomes.

“These data reinforce existing findings and is the first large-scale report of real-world treatment outcomes with neffy during anaphylaxis events. 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. 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,” said Dr. Thomas B. Casale, M.D., 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 in Tampa, Florida. 

The results build on prior data, including a prospective Phase 3 study (n=15), in which patients treated with neffy during OFC-induced anaphylaxis achieved symptom resolution without requiring a second dose. Together, the evidence highlights neffy’s role as a convenient, effective, and patient-friendly epinephrine delivery option, addressing unmet needs in anaphylaxis care.