ARS Pharmaceuticals Announces FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms
ARS Pharmaceuticals (NASDAQ: SPRY) has received FDA approval for neffy® 1 mg, the first needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis, in children aged 4+ years weighing 15-30 kg. The approval marks the first major innovation in epinephrine delivery for this patient population in over 35 years.
The approval is supported by extensive clinical trials showing pharmacokinetic and pharmacodynamic responses comparable to injectable epinephrine. Human factor studies demonstrated effective use by children as young as 10 and untrained caregivers. The device maintains stability at room temperature for 24 months.
neffy 1 mg will be available in the US by May 2025, with most commercially insured patients paying $25 or less for two devices. A cash price of $199 for two doses is available through BlinkRx, with additional support through the neffyConnect program and Patient Assistance Program for eligible individuals.
ARS Pharmaceuticals (NASDAQ: SPRY) ha ricevuto l'approvazione della FDA per neffy® 1 mg, il primo spray nasale di epinefrina senza ago per reazioni allergiche di tipo I, inclusa l'anafilassi, nei bambini di età superiore ai 4 anni con un peso compreso tra 15 e 30 kg. Questa approvazione segna la prima grande innovazione nella somministrazione di epinefrina per questa popolazione di pazienti in oltre 35 anni.
L'approvazione è supportata da ampi studi clinici che mostrano risposte farmacocinetiche e farmacodinamiche comparabili a quelle dell'epinefrina iniettabile. Gli studi sui fattori umani hanno dimostrato un uso efficace da parte di bambini di soli 10 anni e di caregiver non addestrati. Il dispositivo mantiene la stabilità a temperatura ambiente per 24 mesi.
neffy 1 mg sarà disponibile negli Stati Uniti entro maggio 2025, con la maggior parte dei pazienti con assicurazione commerciale che pagheranno 25 dollari o meno per due dispositivi. Un prezzo in contante di 199 dollari per due dosi è disponibile tramite BlinkRx, con ulteriore supporto attraverso il programma neffyConnect e il Programma di Assistenza per i Pazienti per le persone idonee.
ARS Pharmaceuticals (NASDAQ: SPRY) ha recibido la aprobación de la FDA para neffy® 1 mg, el primer aerosol nasal de epinefrina sin aguja para reacciones alérgicas tipo I, incluida la anafilaxia, en niños de 4 años o más que pesen entre 15 y 30 kg. Esta aprobación marca la primera gran innovación en la administración de epinefrina para esta población de pacientes en más de 35 años.
La aprobación está respaldada por amplios ensayos clínicos que muestran respuestas farmacocinéticas y farmacodinámicas comparables a las de la epinefrina inyectable. Los estudios de factores humanos demostraron un uso efectivo por parte de niños tan jóvenes como de 10 años y cuidadores no capacitados. El dispositivo mantiene estabilidad a temperatura ambiente durante 24 meses.
neffy 1 mg estará disponible en EE. UU. para mayo de 2025, con la mayoría de los pacientes asegurados comercialmente pagando 25 dólares o menos por dos dispositivos. Un precio en efectivo de 199 dólares por dos dosis está disponible a través de BlinkRx, con apoyo adicional a través del programa neffyConnect y el Programa de Asistencia para Pacientes para individuos elegibles.
ARS Pharmaceuticals (NASDAQ: SPRY)는 neffy® 1 mg에 대해 FDA 승인을 받았습니다. 이는 4세 이상의 체중 15-30kg인 어린이를 위한 첫 번째 바늘 없는 에피네프린 비강 스프레이로, 제1형 알레르기 반응, 아나필락시스를 포함합니다. 이 승인은 35년 이상 이 환자 집단을 위한 에피네프린 전달의 첫 번째 주요 혁신을 의미합니다.
이 승인은 주사형 에피네프린과 유사한 약리학적 반응을 보여주는 광범위한 임상 시험에 의해 지원됩니다. 인간 요인 연구는 10세 어린이와 훈련되지 않은 보호자가 효과적으로 사용할 수 있음을 입증했습니다. 이 장치는 실온에서 24개월 동안 안정성을 유지합니다.
neffy 1 mg는 2025년 5월까지 미국에서 출시될 예정이며, 대부분의 상업 보험 가입자는 두 개의 장치에 대해 25달러 이하를 지불하게 됩니다. 두 용량에 대한 현금 가격은 BlinkRx를 통해 199달러로 제공되며, neffyConnect 프로그램과 적격 개인을 위한 환자 지원 프로그램을 통해 추가 지원이 제공됩니다.
ARS Pharmaceuticals (NASDAQ: SPRY) a reçu l'approbation de la FDA pour neffy® 1 mg, le premier spray nasal d'épinéphrine sans aiguille pour les réactions allergiques de type I, y compris l'anaphylaxie, chez les enfants de 4 ans et plus pesant entre 15 et 30 kg. Cette approbation marque la première grande innovation dans l'administration de l'épinéphrine pour cette population de patients en plus de 35 ans.
L'approbation est soutenue par d'importants essais cliniques montrant des réponses pharmacocinétiques et pharmacodynamiques comparables à celles de l'épinéphrine injectable. Des études sur les facteurs humains ont démontré une utilisation efficace par des enfants aussi jeunes que 10 ans et des soignants non formés. L'appareil maintient sa stabilité à température ambiante pendant 24 mois.
neffy 1 mg sera disponible aux États-Unis d'ici mai 2025, la plupart des patients assurés commercialement payant 25 dollars ou moins pour deux dispositifs. Un prix au comptant de 199 dollars pour deux doses est disponible via BlinkRx, avec un soutien supplémentaire par le programme neffyConnect et le Programme d'Aide aux Patients pour les personnes éligibles.
ARS Pharmaceuticals (NASDAQ: SPRY) hat die FDA-Zulassung für neffy® 1 mg erhalten, das erste nadelfreie Epinephrin-Nasenspray für Typ-I-Allergische Reaktionen, einschließlich Anaphylaxie, bei Kindern ab 4 Jahren mit einem Gewicht von 15-30 kg. Die Zulassung stellt die erste große Innovation in der Epinephrin-Verabreichung für diese Patientengruppe seit über 35 Jahren dar.
Die Zulassung wird durch umfangreiche klinische Studien gestützt, die pharmakokinetische und pharmakodynamische Reaktionen zeigen, die mit injizierbarem Epinephrin vergleichbar sind. Studien zu menschlichen Faktoren haben gezeigt, dass das Produkt von Kindern ab 10 Jahren und von ungeschulten Pflegekräften effektiv genutzt werden kann. Das Gerät bleibt bei Raumtemperatur 24 Monate stabil.
neffy 1 mg wird in den USA bis Mai 2025 erhältlich sein, wobei die meisten kommerziell versicherten Patienten 25 Dollar oder weniger für zwei Geräte zahlen. Ein Barpreis von 199 Dollar für zwei Dosen ist über BlinkRx erhältlich, mit zusätzlicher Unterstützung durch das neffyConnect-Programm und das Patientenhilfsprogramm für berechtigte Personen.
- First FDA-approved needle-free epinephrine treatment for children
- Large market potential with 40% of epinephrine prescriptions for under-18s
- Competitive pricing at $25 for insured patients
- Strong stability profile with 24-month shelf life
- Multiple distribution channels including retail and school programs
- Product launch delayed until May 2025
- Higher cash price point at $199 compared to some existing alternatives
Insights
The FDA approval of neffy® 1 mg nasal spray represents a significant regulatory achievement for ARS Pharmaceuticals, expanding their addressable market to include pediatric patients (aged 4+ years) weighing 15 to <30kg. This approval is particularly noteworthy as it's the first needle-free epinephrine delivery system approved for younger children with Type I Allergic Reactions, including anaphylaxis.
The approval addresses a well-documented clinical need, with data showing 40% of patients delay treatment due to needle aversion and 56% of caregivers fear using auto-injectors on their children. This translates to substantial market opportunity, considering nearly 40% of U.S. epinephrine prescriptions are written for children under 18, with approximately one-third of those for children in this specific weight range.
The product's differentiated features increase its competitive advantage, including its 24-month room-temperature shelf life, tolerance to temperatures up to 122°F for 3 months, and resilience to freezing. Human factors studies confirm usability by children as young as 10 and untrained caregivers, addressing a critical adoption barrier in emergency situations.
With commercial availability expected by May 2025, ARS Pharma has established comprehensive access programs through neffyConnect, offering most commercially insured patients two devices for $25 or a cash price of $199. This approval completes their epinephrine product portfolio following previous approvals of neffy 2 mg in the U.S. and EURneffy in Europe, positioning the company strategically in the allergic reaction management market.
This FDA approval transforms ARS Pharmaceuticals' market position by addressing a critical gap in pediatric allergy management. The company has now secured approvals across all key weight categories, creating a complete product ecosystem that significantly strengthens their competitive positioning against traditional auto-injector manufacturers.
The timing is strategically valuable, as ARS establishes itself as a first-mover in needle-free epinephrine delivery. With approximately 1 in 13 children having severe food allergies, the addressable market is substantial. The approval's language regarding "first significant innovation in 35 years" provides powerful differentiation messaging for marketing campaigns targeting both healthcare providers and concerned parents.
ARS's multi-pronged commercialization strategy demonstrates sophisticated market planning. Their pricing structure ($199 cash price for two doses) appears calibrated to balance accessibility with profitability, while their insurance coverage program ($25 copay) removes barriers for most commercially insured patients. The neffyinSchools program further drives institutional adoption in a key setting for allergic emergencies.
The product's practical advantages - simplified administration, no hold time, temperature stability, and usability by untrained individuals - directly address well-documented pain points in the current standard of care. These features position neffy to potentially capture significant market share from established products, particularly in the pediatric segment where needle anxiety creates substantial hesitation in critical moments.
neffy 1 mg is the first and only needle-free epinephrine treatment approved for younger children
SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.
In the general population, approximately one in 13 children have severe food allergies, and more than 40 percent have experienced severe reactions.1 Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 percent of patients delay treatment2, and 56 percent of caregivers fear using needle-based auto-injectors on their child3. neffy eliminates needles, delivering a precise epinephrine dose via a simple nasal spray, almost instantly, with no nasal hold time required.
“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms4 —we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”
The approval of neffy 1 mg is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also show children as young as 10 can use neffy effectively by following instructions, and that even untrained individuals, such as babysitters or teachers, can effectively administer neffy. The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to 3 months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability.
“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr. David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”
ARS Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025. The neffyConnect program provides patients, caregivers, and healthcare professionals with information to guide their treatment journey, details about medication fulfillment services, financial support and navigating insurance requirements. Most commercially insured patients will pay no more than
Eligible schools participating in the neffyinSchools program can receive neffy 1 mg upon availability. For more information, and to register for neffyConnect, visit www.neffy.com.
The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30kg ( 66 lb.), and approval for EURneffy in the EU by the European Commission on August 22, 2024.
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) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, 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 expectation that neffy will save lives; the effectiveness of neffy; neffyConnect’s ability to help patients and HCPs access financial support and medication fulfillment services; ARS Pharmaceuticals’ commercial coverage goals and the timing thereof; the expected timing for product availability of neffy 1 mg; neffy’s ability to improved health outcomes and quality of life; neffy’s shelf life and its effectiveness after being subject to extreme temperatures; 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,” “expects,” “if,” “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: 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-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents 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
References:
- Food Allergy Research & Education. Facts and Statistics. Available at Facts and Statistics - FoodAllergy.org. Accessed January 24, 2025.
- Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY).
- 3. Chad L, Ben-Shoshan M, Asai Y, et al. A majority of parents of children with peanut allergy fear using the epinephrine auto-injector. Allergy. 2013;68(12):1605-1609. https://doi.org/10.1111/all.12262.
- ARS Data on File, 2025
FAQ
When will neffy 1 mg (SPRY) be available in the US market?
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What age group and weight range is neffy 1 mg (SPRY) approved for?
How long is the shelf life of neffy 1 mg (SPRY)?
What makes neffy 1 mg (SPRY) different from existing epinephrine treatments?
