ARS Pharmaceuticals’ neffy® (epinephrine nasal spray) 1 mg is Now Available in the United States for Type I Allergic Reactions, including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms

Rhea-AI Summary

ARS Pharmaceuticals (NASDAQ: SPRY) has announced the U.S. availability of neffy® 1 mg, their FDA-approved nasal spray epinephrine for Type I allergic reactions and anaphylaxis in children aged 4+ years weighing 15-30 kg. The needle-free design eliminates the risk of accidental injections, which affects ~3,500 cases annually. Key features include:

- 100% successful dosing rate in human factor studies - 24-month shelf life with temperature tolerance up to 122°F - Available at $199 for two doses (GoodRx price) - Eligible commercially insured patients pay as little as $25 - Partnership progress with major insurers including United Healthcare and Express Scripts

The company is implementing comprehensive support programs, including financial assistance and a Patient Assistance Program for eligible uninsured patients. The neffyinSchools program will provide the medication to participating eligible schools.

Positive

• FDA approval and commercial launch of neffy 1 mg for children weighing 15-30 kg
• 100% successful dosing rate in human factor studies vs. up to 35% error rates with injection devices
• Partnerships with major insurance companies including United Healthcare, Express Scripts, and OptumRx
• Affordable pricing program with eligible commercially insured patients paying only $25
• Strong product features including 24-month shelf life and high temperature tolerance

Negative

• Relatively high cash price of $199 for two doses without insurance coverage
• Limited to specific weight range (15-30 kg) and age group (4+ years)
• Commercial coverage expansion still in progress, may face initial access restrictions

Insights

Pharmaceutical Market Analyst

neffy's pediatric nasal epinephrine spray addresses needle fears and administration errors with strategic pricing and insurance partnerships ahead of allergy seasons.

The commercial availability of neffy® 1 mg epinephrine nasal spray marks a significant milestone for ARS Pharmaceuticals following its March 2025 FDA approval. This product targets a crucial segment—children weighing 15 to <30 kg (33 to <66 lb)—who represent nearly 23% of individuals requiring epinephrine.

The nasal spray format directly addresses three documented challenges in the current emergency allergy treatment landscape:

• Needle phobia, which the company states can delay critical treatment administration
• Administration errors (100% success rate with neffy versus up to 35% error rates with injection devices)
• Approximately 3,500 annual accidental needle injuries to caregivers' hands/fingers

From a market access perspective, ARS has implemented a comprehensive strategy with a $25 copay program for eligible insured patients, a cash price of $199 for two doses, and a Patient Assistance Program for uninsured individuals. The company reports progress with major insurers including United Healthcare, Express Scripts, and OptumRx.

The product's practical features align well with real-world usage needs: backpack/lunchbox portability, 24-month shelf life, temperature stability up to 122°F, and resilience to freezing cycles. The strategic timing before summer travel and back-to-school season demonstrates thoughtful commercialization planning.

The endorsement from FARE (Food Allergy Research & Education) provides additional credibility within the allergy management community, while the neffyinSchools program suggests a dual-track approach targeting both individual prescriptions and institutional adoption.

The availability of neffy 1 mg extends protection to younger, school-aged children—who make up nearly 23% of people needing epinephrine

Visit neffy.com for savings and support programs and pay as little as $25 (if eligible) in preparation for summer travel and back-to-school

SAN DIEGO, May 07, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced neffy^® (epinephrine nasal spray) 1 mg is now available to patients and caregivers by prescription across the U.S. In March 2025, the U.S. Food and Drug Administration approved neffy for the treatment of Type I allergic reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.).

“Many children fear needles, which can lead parents to delay administering needle-based epinephrine treatments. This delay may result in serious consequences,” Eric Karas, Chief Commercial Officer of ARS Pharma, states. “The availability of the 1 mg dose before summer travel, camps, and back-to-school season will help communities better prepare for allergic emergencies. The needle-free design of neffy also eliminates the risk of adverse events, such as accidental injections into the hands or fingers of a child or caregiver, which happens about 3,500 times each year. Now is a great time for parents to reach out to their healthcare providers to ask for neffy as a treatment for their young children.”

neffy is small and designed to be easy-to-use, making it convenient to carry in a backpack or lunchbox. Human factor studies show one hundred percent of users dosed neffy successfully by following instructions, compared with up to 35% error rates with injection devices. The device has a shelf life of 24 months and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to three months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability.

ARS Pharma is committed to access and affordability, and provides comprehensive support programs to patients, caregivers, and healthcare professionals with information to guide their treatment journey, details about medication fulfillment services, financial assistance, and navigating insurance requirements. Eligible commercially insured patients will pay no more than $25 for two single-use neffy devices through a co-pay savings program and some insurers may also provide multiple packs so neffy can be kept handy at school, home, and other caregiving locations. The co-pay savings card will be automatically loaded at many retail pharmacies but can also be accessed at neffy.com, downloaded to an Apple Wallet, and provided to the pharmacy. The cash price for neffy is $199 for two doses on the GoodRx website. For certain uninsured or underinsured U.S. residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost.

“We’ve been focused on working with leading, national insurance companies to ensure that neffy is readily available to patients,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “We are making great progress with United Healthcare, Express Scripts, OptumRx and others, recognizing the value of neffy and we anticipate expanding commercial coverage over the summer so people can get neffy without restrictions or additional paperwork from physicians. We believe this will give young patients and caregivers greater peace of mind as they head into the new school year.”

“The expanded availability of neffy represents real progress for our community, especially for young children who may be more likely to speak up about symptoms of a serious allergic reaction when they know epinephrine can be given without a needle,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education), the leading nonprofit organization dedicated to food allergy. “This news means more families will have options that help them be ready to act and administer ‘Epi first, Epi fast’ when a reaction occurs—in those moments when every second counts. We commend ARS Pharma for its commitment to innovation, access, and the prioritization of the needs of patients with severe food allergy.”

Eligible schools participating in the neffyinSchools program can receive neffy 1 mg upon availability. For more information visit www.neffy.com. Additional details about neffy insurance coverage can be found here.

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 Pharmaceuticals 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 and pediatric patients 4 years of age and older who weigh 15 kg 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 potential market and demand for neffy; the belief that the current availability of neffy 1 mg will help communities prepare ahead of the summer months and back-to-school season; the platforms through which neffy will be accessible, including GoodRx, the ARS Pharma Patient Assistance Program, and neffyinSchools; expectations about the costs of neffy for patients; the belief that ARS Pharma is making progress with insurers and pharmacies and will expand commercial coverage and availability this summer; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer epinephrine; 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,” “if,” “likely,” “may,” “potential,” “on track to,” “plans,” “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: reliance on third parties to promote and sell neffy; the potential safety and other complications from neffy; the ability to maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. 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 Pharmaceuticals’ Quarterly Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025. This document can also be accessed on ARS Pharmaceuticals’ 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 Pharmaceuticals 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

FAQ

What is the cost of SPRY's neffy epinephrine nasal spray?

neffy costs $199 for two doses (GoodRx price). Eligible commercially insured patients can pay as little as $25 through a co-pay savings program. A Patient Assistance Program is available for eligible uninsured patients.

What age group and weight range is neffy 1 mg approved for?

neffy 1 mg is approved for children aged 4 years and older who weigh between 15 to 30 kilograms (33 to 66 pounds).

What insurance companies cover ARS Pharmaceuticals' neffy?

The company is working with major insurers including United Healthcare, Express Scripts, and OptumRx, with plans to expand commercial coverage over summer 2025.

What are the storage requirements for neffy nasal spray?

neffy has a 24-month shelf life and can tolerate temperatures up to 122°F (50°C) for up to three months. If accidentally frozen, it can be thawed without impact on quality.

How effective is SPRY's neffy compared to traditional epinephrine injectors?

Human factor studies showed 100% of users dosed neffy successfully by following instructions, compared to up to 35% error rates with injection devices.