neffy® (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)

Rhea-AI Summary

ARS Pharmaceuticals (NASDAQ:SPRY) has received Japanese regulatory approval for neffy®, the first needle-free epinephrine nasal spray for emergency treatment of allergic reactions (anaphylaxis). The approval covers both 1mg and 2mg doses for adults and children weighing over 15kg.

Through a partnership with Alfresa Holdings, neffy is expected to launch in Japan by Q4 2025. The approval triggers a $2 million milestone payment to ARS Pharma. This breakthrough addresses a significant market need, as approximately 900,000 Japanese individuals are affected by food allergies, yet only 14% of anaphylaxis patients reported having an epinephrine auto-injector prescription.

The product features a 24-month shelf life and is already commercially available in the US and parts of Europe, with additional approvals expected in Canada, Australia, New Zealand, and China by early 2026.

Positive

• First and only needle-free emergency epinephrine treatment approved in Japan
• Large market opportunity with 900,000 Japanese individuals affected by food allergies
• $2 million milestone payment upon Japanese NHI Drug Price List inclusion
• 24-month shelf life, longer than other epinephrine forms
• Global expansion with approvals/launches in US, Europe, and pending in multiple other markets

Negative

• Low current epinephrine auto-injector adoption rate (14%) in Japanese market may indicate challenges in market penetration
• Commercial success depends on successful partnership execution with Alfresa Holdings

Insights

Biotech Regulatory Specialist

Japan's approval of needle-free neffy strengthens ARS Pharma's global position with new $2M milestone and recurring revenue opportunity.

The Japanese approval of neffy, the first needle-free epinephrine treatment for anaphylaxis in that market, represents a significant regulatory milestone for ARS Pharmaceuticals. This approval unlocks a $2 million payment and establishes a new revenue stream through the transfer price arrangement with Alfresa Holdings, their Japanese commercial partner.

The commercial opportunity is substantial, addressing approximately 900,000 Japanese individuals affected by food allergies. Current data shows only 14% of Japanese anaphylaxis patients have an epinephrine auto-injector prescription, and only half of those actually use it during emergencies – indicating significant under-treatment that neffy could address.

This approval reinforces ARS Pharma's global expansion strategy, following their U.S. launch and European entry through partner ALK. With upcoming regulatory decisions expected in Canada, Australia, New Zealand, and China, the company is executing a methodical global rollout through strategic partnerships that minimize direct commercial investment while generating milestone payments and transfer pricing revenue.

The product's differentiation is compelling: needle-free administration addresses documented hesitancy to use injectable options, while the extended 24-month shelf life and compact design improve compliance – critical factors for emergency medications that must be carried consistently. These advantages position neffy to potentially capture significant market share from traditional auto-injectors in multiple global markets.

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 the Japanese National Health Institute (NHI) Drug Price List, ARS Pharma is eligible to receive a final regulatory milestone of $2 million, and to sell neffy to Alfresa at a transfer price. Alfresa expects neffy to be available in the fourth quarter of 2025.

neffy is commercially available in the U.S. 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). Earlier this year, ARS Pharma’s European partner, ALK successfully launched EURneffy in Germany and received approval in the U.K. Regulatory approvals for neffy in Canada (with ALK), Australia and New Zealand (in partnership with CSL), are expected by the end of 2025, with commercial rollouts planned for early 2026. As well, regulatory approval for neffy in China (in partnership with Pediatrix) is expected in the first half of 2026.

About neffy^®

neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)

INDICATION

neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.

IMPORTANT SAFETY INFORMATION

neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

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. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.

Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.

neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.

Common side effects of neffy 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.

Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.

These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, 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.

Please see the full Prescribing Information and Patient Information for neffy.

About Type I Allergic Reactions Including Anaphylaxis

Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. 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. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. 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.

About ARS Pharmaceuticals, Inc.

ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy^® (trade name EURneffy^® in the EU), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients 4 years of age and older who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.

Forward Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the patient benefits and effectiveness of neffy, including its needle-free, compact, portable and easy to use design, temperature stability, and extended shelf life; the potential market and demand for neffy; the anticipated timing of regulatory decisions for neffy in Canada, Australia and New Zealand, and China; and the expected timing of commercial launches in Japan, Canada, and Australia and New Zealand; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track to/for,” “potential,” “plan,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; the ability to obtain and maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s’ ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 13, 2025. This document can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.

ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com

ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com 

References

1. Yoshisue, Hajime, Yuji Homma, Chie Ito, and Motohiro Ebisawa. "Prevalence of food allergy increased 1.7 times in the past 10 years among Japanese patients below 6 years of age." Pediatric Allergy and Immunology, published online July 15, 2024. https://doi.org/10.1111/pai.14192.
2. Nakamura, Yoichi, Yoko Hashiba, Masashi Furuie, Kaori Okayasu, Atsushi Isozaki, Yuko Hasebe, and Mariko Kaburaki. "Internet survey on EpiPen adrenaline autoinjector usage in Japanese patients with a history of anaphylaxis." Asia Pacific Allergy, published online June 10, 2025. https://doi.org/10.5415/apallergy.0000000000000209

FAQ

When will neffy nasal spray be available in Japan?

Alfresa Holdings expects to launch neffy in Japan during the fourth quarter of 2025, following its recent regulatory approval.

What dosages of neffy (SPRY) were approved in Japan?

The PMDA approved both 1mg and 2mg doses of neffy for emergency treatment of allergic reactions in adults and children weighing more than 15kg.

How many people in Japan could benefit from neffy nasal spray?

Approximately 900,000 Japanese individuals are affected by food allergies, with prevalence in children doubling from 2010 to 2019.

What milestone payment will ARS Pharmaceuticals (SPRY) receive for neffy's Japanese approval?

ARS Pharma will receive a $2 million regulatory milestone payment after neffy is listed on the Japanese National Health Institute Drug Price List.

How long is neffy's shelf life compared to other epinephrine products?

neffy has an extended shelf life of 24 months, which is longer than other forms of epinephrine.

In which other countries is ARS Pharmaceuticals (SPRY) planning to launch neffy?

neffy is already available in the US and parts of Europe, with approvals expected in Canada, Australia, New Zealand by end of 2025, and China by first half of 2026.