Real-World Evidence Supports Clinical Effectiveness of neffy® (epinephrine nasal spray) in Patients Experiencing Anaphylaxis
ARS Pharmaceuticals (NASDAQ:SPRY) has reported compelling real-world evidence for its neffy® (epinephrine nasal spray) in treating anaphylaxis. The study, accepted for publication in the Annals of Allergy, Asthma and Immunology, demonstrated that 89.2% of 545 patients experiencing anaphylaxis during oral food challenges and allergen immunotherapy were successfully treated with a single dose of neffy.
This success rate closely mirrors the 88.9% efficacy rate historically reported for traditional epinephrine injections, suggesting clinical interchangeability between the two delivery methods. The findings build upon previous clinical evidence, including a Phase 3 study, and represent the first large-scale analysis of neffy's treatment outcomes in routine clinical practice.
ARS Pharmaceuticals (NASDAQ:SPRY) ha pubblicato dati real-world convincenti sull'impiego di neffy® (spray nasale di epinefrina) nel trattamento dell'anafilassi. Lo studio, accettato per la pubblicazione sulle Annals of Allergy, Asthma and Immunology, ha mostrato che 89,2% dei 545 pazienti che hanno manifestato anafilassi durante challenge alimentari orali e immunoterapia per allergeni sono stati trattati con successo con una singola somministrazione di neffy.
Questa percentuale di successo è molto vicina al tasso di efficacia dell'88,9% riportato storicamente per le iniezioni tradizionali di epinefrina, suggerendo una possibile intercambiabilità clinica tra le due modalità di somministrazione. I risultati confermano e ampliano le evidenze cliniche precedenti, incluso uno studio di fase 3, e costituiscono la prima analisi su larga scala degli esiti di trattamento con neffy nella pratica clinica di routine.
ARS Pharmaceuticals (NASDAQ:SPRY) ha presentado evidencia del mundo real sobre el uso de neffy® (spray nasal de epinefrina) en el tratamiento de la anafilaxia. El estudio, aceptado para publicación en las Annals of Allergy, Asthma and Immunology, mostró que el 89,2% de 545 pacientes que sufrieron anafilaxia durante desafíos alimentarios orales y en inmunoterapia con alérgenos fueron tratadas con éxito con una sola dosis de neffy.
Esta tasa de éxito se parece mucho a la tasa de eficacia del 88,9% históricamente asociada a las inyecciones tradicionales de epinefrina, lo que sugiere una posible intercambiabilidad clínica entre ambas vías de administración. Los hallazgos amplían la evidencia clínica previa, incluido un estudio de fase 3, y constituyen el primer análisis a gran escala de los resultados de neffy en la práctica clínica habitual.
ARS Pharmaceuticals (NASDAQ:SPRY)는 아나필락시스 치료에서 neffy®(에피네프린 비강 스프레이)의 실제 진료 근거를 보고했습니다. Annals of Allergy, Asthma and Immunology에 게재가 확정된 이 연구는 경구 음식 도전 및 알레르겐 면역치료 중 아나필락시스를 겪은 545명 중 89.2%가 네피 한 회 투여로 성공적으로 치료되었음을 보여주었습니다.
이 성공률은 전통적인 에피네프린 주사에서 과거 보고된 88.9%의 효능과 거의 일치해 두 투여 방식 간 임상적 상호대체 가능성을 시사합니다. 이 결과는 3상 연구를 포함한 이전 임상 근거를 뒷받침하며, 일상 임상에서 네피의 치료 결과를 대규모로 분석한 첫 연구라는 의미가 있습니다.
ARS Pharmaceuticals (NASDAQ:SPRY) a publié des données en conditions réelles convaincantes sur l'utilisation de neffy® (spray nasal d'épinéphrine) pour traiter l'anaphylaxie. L'étude, acceptée pour publication dans les Annals of Allergy, Asthma and Immunology, a montré que 89,2 % des 545 patients ayant présenté une anaphylaxie lors de tests d'exposition alimentaire orale et d'immunothérapie allergénique ont été traités avec succès par une seule dose de neffy.
Ce taux de succès est très proche du taux d'efficacité de 88,9 % historiquement associé aux injections traditionnelles d'épinéphrine, ce qui suggère une interchangeabilité clinique entre les deux modes d'administration. Ces résultats complètent les preuves cliniques antérieures, dont une étude de phase 3, et constituent la première analyse à grande échelle des résultats de traitement par neffy en pratique courante.
ARS Pharmaceuticals (NASDAQ:SPRY) hat überzeugende Real-World-Daten zum Einsatz von neffy® (Epinephrin-Nasenspray) bei der Behandlung von Anaphylaxie vorgelegt. Die zur Veröffentlichung in den Annals of Allergy, Asthma and Immunology angenommene Studie zeigte, dass 89,2 % von 545 Patienten, die während oraler Nahrungsmittelprovokationen und Allergen-Immuntherapien eine Anaphylaxie erlitten, mit einer einzigen Dosis neffy erfolgreich behandelt wurden.
Diese Erfolgsrate entspricht weitgehend der historisch berichteten 88,9% Wirksamkeit von traditionellen Epinephrin-Injektionen und deutet auf eine klinische Austauschbarkeit der beiden Applikationsformen hin. Die Ergebnisse bauen auf früheren klinischen Daten, darunter einer Phase‑3‑Studie, auf und stellen die erste groß angelegte Analyse der Behandlungsergebnisse von neffy in der Routinepraxis dar.
- High success rate of 89.2% with single dose treatment in 545 patients
- Real-world effectiveness matches historical epinephrine injection success rates of 88.9%
- Results suggest clinical interchangeability with traditional epinephrine injections
- Findings accepted for publication in prestigious medical journal
- None.
Insights
Real-world data shows neffy nasal spray treats anaphylaxis as effectively as traditional injections, strengthening its market position.
The real-world evidence for neffy® (epinephrine nasal spray) represents a significant clinical validation for ARS Pharmaceuticals' commercial product. The data showing 89.2% of 545 patients being successfully treated with a single dose mirrors the 88.9% success rate historically reported for injectable epinephrine - essentially demonstrating clinical interchangeability between the two administration routes.
This large-scale analysis carries substantial regulatory weight as it moves beyond the initial Phase 3 study (which included only 15 patients) to provide robust evidence from actual clinical practice. The acceptance for publication in the Annals of Allergy, Asthma and Immunology - the official journal of the American College of Allergy, Asthma and Immunology - adds scientific credibility and peer recognition.
What makes this particularly valuable is how it addresses a critical limitation in the original approval data. The FDA typically requires substantial efficacy evidence, and this real-world data significantly expands the patient population demonstrating benefit from 15 patients to 545 patients. This strengthens neffy's positioning with healthcare providers, payers, and pharmacy benefit managers who make formulary decisions.
For patients with severe allergies, a nasal spray alternative to injections represents a meaningful advancement in treatment accessibility and potential compliance. The consistency between clinical trial results and real-world outcomes suggests the product performs reliably in everyday medical settings, which is crucial for emergency treatments where failure rates must be minimized.
Findings accepted for publication in the official journal of the American College of Allergy, Asthma and Immunology
About 9 out of every 10 patients experiencing anaphylaxis were effectively treated with a single dose of neffy
Results suggest real-world effectiveness of neffy is consistent with that historically reported for epinephrine injection
SAN DIEGO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today shares real-world evidence evaluating the clinical performance of neffy® (epinephrine nasal spray) in patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy. These findings represent the first large-scale analysis of treatment outcomes with neffy during routine clinical practice and was accepted in August for publishing as a correspondence in the Annals of Allergy, Asthma and Immunology, the official journal of the American College of Allergy, Asthma and Immunology.
Nearly
Importantly, these real-world data build upon previously published clinical evidence, including a prospective Phase 3 study2 (n = 15 patients) assessing the efficacy of neffy for the treatment of oral food challenge-induced anaphylaxis symptoms. In that study, no patients required a second dose of neffy for treatment of the initial anaphylactic reaction.
“These data reinforce existing findings and is the first large-scale report of real-world treatment outcomes with neffy during anaphylaxis events. The finding that about 9 out of every 10 patients were successfully treated with a single dose of neffy in more than 500 patients is essentially identical to the historic response rates observed with epinephrine injection,” said Dr. Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Florida. “We believe these real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection, building on the clinical studies conducted for FDA approval that showed neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”
Figure 1: Treatment success rate with a single dose of neffy administered by a healthcare provider during oral food challenge and allergen immunotherapy during the neffy experience program (n = 545 patients) compared to historic control treatment success rate with a single dose of epinephrine injection administered by a healthcare provider during food-induced anaphylaxis as reported by Patel et. al. JACI, 2021 (n = 12,615 patients).
About the neffy Experience Program
The data from this retrospective observational analysis was collected from healthcare providers participating in the neffy experience program. In the neffy experience program, healthcare providers were given six doses of neffy for use to rescue patients experiencing anaphylaxis symptoms during oral food challenge or allergen immunotherapy. neffy labeling states that a second dose should be administered if anaphylaxis symptoms continue or get worse starting 5 minutes after the first dose.
As of the March 2025 data cut-off, 301 healthcare providers had responded to the survey instrument, and a total of 545 patients were reported having been treated with neffy 2 mg. Four hundred and eighty-six (486) of these patients had been successfully treated with a single dose of neffy 2 mg, with the remaining 59 patients requiring a second dose of epinephrine. The neffy experience program is actively ongoing and now includes both the 2 mg and 1 mg doses.
This data from the neffy experience program is consistent with clinical trials recently published on the real-world clinical effectiveness of neffy. However, this observational analysis differs from a randomized clinical trial in several ways. The studies have different endpoints and there are inherent limitations in real-world observational studies, including lack of randomization, lack of uniform timing or type of clinical assessments and challenges with missing data.
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: expectations and evaluations regarding the clinical performance and patient benefits of neffy, including its needle-free, portable and easy to use design; the belief that real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection; and the beliefs that such data will continue to build on the clinical studies of neffy conducted for FDA approval that showed neffy achieved blood levels and pharmacodynamic responses within the range of approved epinephrine injection products and on previously published clinical evidence, including a prospective Phase 3 study assessing the efficacy of neffy for the treatment of oral food challenge-induced anaphylaxis symptoms; 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,” “potential,” “plan,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s 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 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 March 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on May 14, 2025 and 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. These documents 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.
Investor Contact:
Justin Chakma, ARS Pharma
justinc@ars-pharma.com
Media Contact:
Christy Curran, Sam Brown Inc.
christycurran@sambrown.com
615.414.8668
References
1 Patel N, Chong KW, Yip AYG, Ierodiakonou D, Barta J, Boyle RJ, et al. Use of multiple epinephrine doses in anaphylaxis: a systematic review and meta-analysis. J Allergy Clin Immunol. 2021;148(5):1307-1315.
2 Ebisawa M, Takahashi K, Takahashi KK, Yanagida N, Sato S, Lieberman J, et al. Epinephrine nasal spray improves allergic symptoms in patients undergoing oral food challenge, phase 3 trial. J Allergy Clin Immunol. 2025; doi:10.1016/j.jaip.2025.06.038.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/890e02e2-e6bc-4c22-a1cf-a5b0a47fc286
FAQ
What is the success rate of neffy nasal spray in treating anaphylaxis?
How does neffy compare to traditional epinephrine injections for anaphylaxis?
What clinical evidence supports SPRY's neffy nasal spray effectiveness?
Where will the neffy clinical effectiveness study be published?
What types of anaphylaxis cases were studied in the neffy real-world evidence?
