It has been found in real-world data from over 500 patients that a single dose of ARS Pharmaceuticals’epinephrine nasal spray(neffy) achieved an 89% success rate, comparable to injection outcomes. This large-scale analysis supports neffy as a needle-free alternative for treatinganaphylaxis. These findings represent the first large-scale analysis of treatment outcomes with neffy during routine clinical practice and was accepted in August for publishing as a correspondence in the Annals of Allergy, Asthma and Immunology, the official journal of the American College of Allergy, Asthma and Immunology. Nearly 90% (89.2%) of 545 patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy were successfully treated with a single dose of neffy by a healthcare provider. Meta-analyses report a similar proportion of patients, 88.9%, being successfully treated with a single dose of epinephrine intramuscular injection or auto-injector by a healthcare provider for food-induced anaphylaxis.1 This highly similar treatment success rate supports that the real-world clinical effectiveness of neffy in anaphylaxis is consistent with epinephrine injection. Importantly, these real-world data build upon previously published clinical evidence, including a prospective Phase 3 study2 (n = 15 patients) assessing the efficacy of neffy for the treatment of oral food challenge-induced anaphylaxis symptoms. In that study, no patients required a second dose of neffy for treatment of the initial anaphylactic reaction. “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,” 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. “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.” Figure 1: Treatment success rate with a single dose of neffy administered by a healthcare provider during oral food challenge and allergen immunotherapy during the neffy experience program (n = 545 patients) compared to historic control treatment success rate with a single dose of epinephrine injection administered by a healthcare provider during food-induced anaphylaxis as reported by Patel et. al. JACI, 2021 (n = 12,615 patients). neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.