ARS Pharma’s Neffy® Nasal Spray Wins Japanese Approval for Emergency Anaphylaxis Treatment

ARS Pharmaceuticals, Inc., a biopharma company focused on protecting patients at risk of severe allergic reactions, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved neffy® (epinephrine nasal spray) in 1 mg and 2 mg doses. The treatment is indicated for emergency use in anaphylaxis in adults and children weighing more than 15 kilograms. 

Food allergies affect roughly 900,000 people in Japan, with childhood prevalence nearly doubling between 2010 and 2019. Yet, a 2025 survey revealed gaps in emergency response: only 14% of patients who had experienced anaphylaxis reported having an epinephrine auto-injector prescription, and just half used it during their most recent episode. Many instead sought hospital treatment.

“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. 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,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. 

ARS Pharma partnered with Alfresa Holdings in 2020, granting the company exclusive rights to commercialize neffy in Japan. Following its inclusion on the National Health Institute (NHI) Drug Price List, ARS Pharma will receive a $2 million milestone payment and will supply Alfresa with neffy at a transfer price. Alfresa plans to launch the nasal spray in Japan in Q4 2025.

Neffy is already available in the U.S. for adults and children aged four years and older weighing at least 15 kg. The product was launched in Germany earlier this year under ARS Pharma’s European partner ALK and has received approval in the U.K. Additional regulatory decisions are expected in Canada, Australia, New Zealand, and China through 2025 and 2026, with rollouts planned shortly after approval.