neffy® (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)

Core Viewpoint - ARS Pharmaceuticals has received approval from Japanese regulators for neffy, a needle-free epinephrine nasal spray, which addresses a significant need for emergency treatment of anaphylaxis in both adults and children in Japan [1][2] Group 1: Product Approval and Market Entry - The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved neffy in 1 mg and 2 mg doses for emergency treatment of allergic reactions in individuals weighing over 15 kg [1] - Alfresa Holdings, which holds the marketing rights for neffy in Japan, anticipates that the product will be available in the fourth quarter of 2025 [1][3] Group 2: Market Need and Patient Statistics - Approximately 900,000 individuals in Japan are estimated to be affected by food allergies, with the prevalence in children doubling from 2010 to 2019 [2] - A survey conducted in 2025 revealed that only 14% of Japanese patients who experienced anaphylaxis had an epinephrine auto-injector prescription, and only half used it during their most recent episode [2] Group 3: Product Features and Advantages - Neffy offers a compact design with an extended shelf life of 24 months, making it easier for patients and caregivers to carry and administer during emergencies [2] - The product is already commercially available in the U.S. and has received regulatory approvals in Germany and the U.K., with further approvals expected in Canada, Australia, New Zealand, and China by 2026 [4]