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neffy® (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)
neffy 1 mg and 2 mg doses approved by Japanese regulators neffy offers a new delivery method for epinephrine in Japan for adults and children (>15 kg) living
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"neffy 1 mg and 2 mg doses approved by Japanese regulators neffy offers a new delivery method for epinephrine in Japan for adults and children (>15 kg) living with severe allergic reactions Alfresa Holdings, which owns the rights to market neffy in Japan, expects availability in Q4 2025 SAN DIEGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese authority responsible for the scientific review of drugs and medical devices, has granted approval for neffy® (epinephrine nasal spray) 1 mg and 2 mg doses, for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 15 kilograms. “We are proud to receive this approval in partnership with Alfresa, which broadens access of neffy and offers the first needle-free epinephrine treatment available in Japan for both adults and children with severe allergies,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “This represents a significant breakthrough as neffy meets a vital need for patients who may not carry, or hesitate to use, an injectable option for use during emergencies. With its compact design, and extended shelf life, compared to other forms of epinephrine, of 24 months, this advancement empowers patients and caregivers to consistently carry and administer epinephrine at the earliest signs of a severe reaction.” Approximately 900,000 Japanese individuals are estimated to be affected by food allergies, with the prevalence in children doubling from 2010 to 2019.1 In a 2025 survey of Japanese patients who had experienced anaphylaxis, only 14% reported they had an epinephrine auto-injector prescription, and only half used their epinephrine auto-injector at the time of their most recent anaphylactic episode. The remainder visited a hospital or clinic to receive treatment.2 In 2020, ARS Pharma entered into an exclusive licensing agreement with Japanese pharmaceutical company, Alfresa Holdings, granting them the rights to commercialize neffy (epinephrine nasal spray) in Japan. Under the terms of the agreement, following listing of neffy on...