ARS Pharmaceuticals Announces FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

Core Viewpoint - The FDA has approved neffy® 1 mg, a needle-free epinephrine nasal spray, for treating Type I allergic reactions, including anaphylaxis, in children aged 4 years and older weighing between 15 to < 30 kilograms, marking a significant innovation in epinephrine delivery for this demographic in over 35 years [1][3]. Group 1: Product Details - Neffy 1 mg is the first needle-free epinephrine treatment approved for younger children, providing a precise dose via a nasal spray without the need for a nasal hold time [1][2]. - The device has a shelf-life of 24 months at room temperature and can withstand temperatures up to 122°F (50°C) for up to 3 months [3]. - Neffy can be effectively used by children as young as 10 and even by untrained individuals, such as babysitters or teachers [3]. Group 2: Market Context - Approximately one in 13 children in the general population have severe food allergies, with over 40% experiencing severe reactions [2]. - Despite the benefits of early epinephrine use, around 40% of patients delay treatment, and 56% of caregivers are apprehensive about using needle-based auto-injectors [2][16]. - Nearly 40% of U.S. epinephrine prescriptions are written for children under 18, with a significant portion for those weighing 15 to 30 kilograms [3]. Group 3: Company Commitment and Accessibility - ARS Pharmaceuticals aims to enhance access and affordability for neffy 1 mg, with most commercially insured patients expected to pay no more than $25 for two devices through a co-pay savings program [4]. - The neffyConnect program will assist patients and caregivers with treatment guidance, medication fulfillment, and financial support [4]. - The neffy 1 mg is anticipated to be available in the U.S. by the end of May 2025 [4][5].