Regulators in Japan have cleared neffy epinephrine nasal spray for emergency use in adults and children, offering an alternative to injectable treatments for life-threatening allergies.
RT’s Three Key Takeaways:
- Needle-Free Administration: The Pharmaceuticals and Medical Devices Agency approved 1 mg and 2 mg doses of neffy, providing the first needle-free emergency treatment for anaphylaxis in Japan.
- Improving Patient Adherence: Research shows many Japanese patients hesitate to use injectable epinephrine during emergencies, highlighting a clinical need for the compact, 24-month shelf-life nasal spray.
- Global Commercial Expansion: Already available in the United States (US) and parts of Europe, the treatment is expected to be available in the Japanese market by the fourth quarter of 2025.
The Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for neffy (epinephrine nasal spray) 1 mg and 2 mg doses for the emergency treatment of allergic reactions in Japan, according to a news release from ARS Pharmaceuticals.
The approval covers adults and children who weigh more than 15 kilograms. This marks the first needle-free epinephrine option available in Japan for patients at risk of anaphylaxis.
“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,” said Richard Lowenthal, co-founder, president and chief executive officer (CEO) of ARS Pharma, in a news release. “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.”
Food allergies affect approximately 900,000 individuals in Japan, with the prevalence among children doubling between 2010 and 2019. Despite the risks, a 2025 survey of Japanese patients who experienced anaphylaxis found that only 14% had a prescription for an epinephrine auto-injector. Furthermore, only half of those with a prescription used the device during their most recent episode, with many opting to visit a clinic or hospital for treatment instead.
Alfresa Holdings holds the rights to market the treatment in Japan and expects the product to be available in the fourth quarter of 2025. The agreement follows a 2020 licensing deal between the two companies. Following the listing of the spray on the Japanese National Health Institute (NHI) Drug Price List, ARS Pharma is eligible to receive a final regulatory milestone of $2 million.
The nasal spray is currently available in the US for adults and children aged 4 years and older who weigh at least 15 kilograms. It has also launched in Germany and received approval in the United Kingdom (UK). ARS Pharmaceuticals expects further regulatory decisions in Canada, Australia, and New Zealand by the end of 2025, with a China launch anticipated in the first half of 2026.
The treatment is indicated for type I allergic reactions caused by foods, medicines, insect stings, or other triggers. Common side effects reported include nasal discomfort, headache, throat irritation, chest and nasal congestion, and dizziness. Healthcare providers are advised to screen patients for underlying heart problems, kidney issues, or structural nasal conditions before prescribing. Patients are advised to carry two nasal sprays at all times, as a second dose may be required if symptoms continue or return.
