The U.S. Food and Drug Administration (FDA) has approved Neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, for the emergency treatment of Type I allergic reactions, including anaphylaxis, in children aged four years and older (33–66 lbs.).
This approval marks the first significant advancement in pediatric epinephrine delivery in over 30 years.
Epinephrine remains the first-line treatment for anaphylaxis, yet research indicates that delays in administration are common due to apprehension regarding needle-based auto-injectors.
Neffy addresses this barrier to potential use by providing a precise, needle-free delivery system that simplifies emergency intervention.
Clinical trials have demonstrated its pharmacokinetic and pharmacodynamic equivalency to traditional epinephrine injections, with minimal side effects.
Designed for stability, Neffy maintains efficacy for 24 months at room temperature and withstands extreme temperatures, ensuring reliability in diverse conditions.
The device is user-friendly, enabling non-medical personnel, such as teachers and caregivers, to administer life-saving treatment effectively.
The nasal spray will be available in the U.S. starting May 2025, with affordability initiatives, including co-pay savings and patient assistance programs, ensuring broader accessibility.
The approval of Neffy reflects a growing shift toward needle-free epinephrine solutions, improving anaphylaxis management and patient outcomes in both pre-hospital and in-hospital settings.
For more information access the Medtigo link.
Further Reading:
ARS Pharmaceuticals (2025) FDA Approval of Neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms Accessed March 5, 2024
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