FDA approval of neffy (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis – ARS Pharmaceuticals

ARS Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced that the FDA approved neffy (epinephrine nasal spray) 2 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh greater than 30 kg (66 lbs.).

The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.

“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said 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. “FDA approval of neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.”