Japan Approves neffy: First Needle-Free Emergency Allergy Treatment Offers New Hope

Historic Approval for neffy Marks a Shift in Allergy Care in Japan

On September 19, ARS Pharmaceuticals announced a breakthrough: Japan’s Pharmaceuticals and Medical Devices Agency has approved neffy, the first and only needle-free epinephrine nasal spray for emergency treatment of allergic reactions, including anaphylaxis, in adults and children weighing over 15 kg. This move stands to transform how patients manage life-threatening allergic reactions by introducing an alternative to injectable devices—often feared or left behind by those at risk.

Why This Matters: Bridging the Gaps in Allergy Emergency Preparedness

Despite a population of roughly 900,000 individuals in Japan affected by food allergies—and a doubling in childhood prevalence over the past decade—recent surveys highlight critical gaps in preparedness. Only 14% of patients who experienced anaphylaxis reported having an epinephrine auto-injector prescription, and just half of them actually used it during an episode. The majority either went without immediate treatment or had to seek help at a hospital or clinic.

This approval is particularly meaningful in Japan, where reluctance to carry or use needles hinders rapid treatment during severe allergic events. By offering a compact, needle-free, and easy-to-use nasal spray, neffy aims to overcome key barriers that have contributed to underutilization of epinephrine—an essential life-saving therapy.

neffy: Convenience and Extended Shelf Life to Drive Adoption

With both 1 mg and 2 mg doses approved, neffy’s design includes a 24-month shelf life and easy portability. The anticipated commercial launch by Alfresa Holdings is expected in the fourth quarter of 2025, pending inclusion in Japan’s National Health Institute Drug Price List. For comparison, neffy is already commercially available in the U.S. and Europe, and further regulatory decisions are on track in Canada, Australia, New Zealand, and China through 2026.

Market and Patient Impact: Addressing the Limitations of Injectables

Studies cited by ARS Pharma show that fear of needles, portability, safety concerns, and complex devices often lead to delays or omission of epinephrine treatment—leaving many patients at greater risk. With 40 million Americans experiencing Type I allergic reactions and 20 million having received emergency care in recent years, the market for more accessible and patient-friendly options is clear.

In Japan, Alfresa’s rights to commercialize neffy represent an important opportunity to meet a long-standing clinical need. Under the licensing agreement, ARS Pharma is set to receive a final $2 million milestone payment upon listing, and supply the product at a transfer price.

Key Takeaway: neffy Approval Signals Innovation and a Potential Uptick in Patient Safety

While injectable epinephrine remains a mainstay of anaphylaxis treatment, Japan’s approval of neffy marks a new era of accessibility and choice for patients and caregivers. This move not only positions ARS Pharmaceuticals as an innovator in emergency allergy care, but also prompts broader questions: Will this nasal spray approach help overcome cultural barriers to timely treatment? And could we see similar needle-free options become the standard of care worldwide?

As availability approaches in Japan, the coming years may reveal how much this innovation improves outcomes for people living with severe allergies—and how rapidly patient and physician preferences evolve when ease of use meets urgent medical need.

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