In Japan, neffy® has been endorsed as the sole, needle-free option for immediate treatment of allergic emergencies.
In a significant development for individuals living with severe allergies, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has granted approval for neffy® (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 15 kilograms. This new delivery method offers a potential lifesaving solution for those affected by allergies in Japan.
Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen. Epinephrine, the active ingredient in neffy, is a well-known medicine used to treat these emergencies.
However, it's crucial to note that the use of neffy may cause serious side effects. Common side effects include nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.
It's essential for patients to refer to the full Prescribing Information and Patient Information for neffy. If any side effects bother them or do not go away, they should tell their healthcare provider. For medical advice about side effects, patients can contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
While epinephrine auto-injectors have been shown to be highly effective, there are well-published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. 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.
It's important to emphasise that even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency. This underscores the need for alternative delivery methods like neffy.
Approximately 40 million people in the United States experience Type I allergic reactions, and approximately 900,000 Japanese individuals are estimated to be affected by food allergies, with the prevalence in children doubling from 2010 to 2019.
ARS Pharma, the biopharmaceutical company responsible for neffy, is eligible to receive a final regulatory milestone of $2 million upon listing of neffy on the Japanese National Health Institute (NHI) Drug Price List. Alfresa Holdings, which owns the rights to market neffy in Japan, expects availability in Q4 2025.
Regulatory approvals for neffy in Canada, Australia, New Zealand, Europe (Germany and the U.K.), and China are expected by the end of 2025 or early 2026. In the U.S., neffy is commercially available for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children aged 4 years and older who weigh at least 33 pounds (15 kg).
Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. For those living with severe allergies, neffy could be a game-changer, offering a new and potentially more accessible method for treating life-threatening allergic reactions.
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