ARS Pharmaceuticals to Showcase Innovation and Present Data on neffy® (epinephrine nasal spray) at 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting
ARS Pharmaceuticals (NASDAQ: SPRY) announced nine presentations featuring data on neffy® (epinephrine nasal spray) at the 2025 AAAAI Annual Scientific Meeting. Key highlights include an oral presentation showing neffy's superior efficacy in Japanese patients during food challenges, with lower symptom scores within 10 minutes compared to traditional treatments.
The presentations will showcase comprehensive clinical research data, including pharmacokinetics and pharmacodynamics studies in Chinese subjects, demonstrating neffy's comparable efficacy and safety to intramuscular injection under various conditions. The studies confirm neffy's effectiveness in children four years or older weighing more than 15 kilograms.
neffy is the first and only FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30 kg (66 lbs). The event will be held from February 28 to March 3, 2025, in San Diego, California.
ARS Pharmaceuticals (NASDAQ: SPRY) ha annunciato nove presentazioni contenenti dati su neffy® (spray nasale di epinefrina) durante il 2025 AAAAI Annual Scientific Meeting. I punti salienti includono una presentazione orale che mostra l'efficacia superiore di neffy nei pazienti giapponesi durante le sfide alimentari, con punteggi dei sintomi inferiori entro 10 minuti rispetto ai trattamenti tradizionali.
Le presentazioni mostreranno dati completi di ricerca clinica, inclusi studi di farmacocinetica e farmacodinamica su soggetti cinesi, dimostrando l'efficacia e la sicurezza comparabili di neffy rispetto all'iniezione intramuscolare in varie condizioni. Gli studi confermano l'efficacia di neffy nei bambini di quattro anni o più che pesano più di 15 chilogrammi.
neffy è il primo e unico trattamento approvato dalla FDA senza ago per le reazioni allergiche di tipo I, inclusa l'anafilassi, in adulti e bambini che pesano ≥30 kg (66 lbs). L'evento si terrà dal 28 febbraio al 3 marzo 2025 a San Diego, California.
ARS Pharmaceuticals (NASDAQ: SPRY) anunció nueve presentaciones que presentan datos sobre neffy® (spray nasal de epinefrina) en la Reunión Anual Científica AAAAI 2025. Los puntos destacados incluyen una presentación oral que muestra la eficacia superior de neffy en pacientes japoneses durante desafíos alimentarios, con puntuaciones de síntomas más bajas dentro de los 10 minutos en comparación con tratamientos tradicionales.
Las presentaciones mostrarán datos completos de investigación clínica, incluidos estudios de farmacocinética y farmacodinamia en sujetos chinos, demostrando la eficacia y seguridad comparables de neffy en comparación con la inyección intramuscular bajo diversas condiciones. Los estudios confirman la efectividad de neffy en niños de cuatro años o más que pesen más de 15 kilogramos.
neffy es el primer y único tratamiento aprobado por la FDA sin aguja para reacciones alérgicas tipo I, incluida la anafilaxis, en adultos y niños que pesen ≥30 kg (66 lbs). El evento se llevará a cabo del 28 de febrero al 3 de marzo de 2025 en San Diego, California.
ARS Pharmaceuticals (NASDAQ: SPRY)는 2025 AAAAI 연례 과학 회의에서 neffy® (에피네프린 비강 스프레이)에 대한 데이터를 포함한 아홉 개의 발표를 발표했습니다. 주요 하이라이트로는 음식 도전 중 일본 환자에서 neffy의 우수한 효능을 보여주는 구두 발표가 있으며, 전통적인 치료법에 비해 10분 이내에 더 낮은 증상 점수를 기록했습니다.
발표에서는 중국 피험자에 대한 약리학적 동태 및 약리학적 작용 연구를 포함한 종합적인 임상 연구 데이터를 보여주며, 다양한 조건에서 neffy의 근육 주사와 비교 가능한 효능 및 안전성을 입증합니다. 연구 결과는 15킬로그램 이상 체중의 4세 이상의 어린이에게서 neffy의 효능을 확인합니다.
neffy는 성인과 체중 ≥30 kg (66 lbs)의 어린이에 대한 아나필락시스를 포함한 제1형 알레르기 반응에 대해 FDA 승인을 받은 최초이자 유일한 바늘 없는 치료제입니다. 이 행사는 2025년 2월 28일부터 3월 3일까지 캘리포니아 샌디에이고에서 열립니다.
ARS Pharmaceuticals (NASDAQ: SPRY) a annoncé neuf présentations présentant des données sur neffy® (spray nasal d'épinéphrine) lors de la Réunion Scientifique Annuelle AAAAI 2025. Les points forts incluent une présentation orale montrant l'efficacité supérieure de neffy chez des patients japonais lors de défis alimentaires, avec des scores de symptômes inférieurs dans les 10 minutes par rapport aux traitements traditionnels.
Les présentations mettront en avant des données complètes de recherche clinique, y compris des études de pharmacocinétique et de pharmacodynamie chez des sujets chinois, démontrant l'efficacité et la sécurité comparables de neffy par rapport à l'injection intramusculaire dans diverses conditions. Les études confirment l'efficacité de neffy chez les enfants de quatre ans ou plus pesant plus de 15 kilogrammes.
neffy est le premier et unique traitement sans aiguille approuvé par la FDA pour les réactions allergiques de type I, y compris l'anaphylaxie, chez les adultes et les enfants pesant ≥30 kg (66 lbs). L'événement se tiendra du 28 février au 3 mars 2025 à San Diego, Californie.
ARS Pharmaceuticals (NASDAQ: SPRY) kündigte neun Präsentationen an, die Daten zu neffy® (Epinephrin-Nasenspray) auf dem 2025 AAAAI Annual Scientific Meeting präsentieren. Zu den wichtigsten Highlights gehört eine mündliche Präsentation, die die überlegene Wirksamkeit von neffy bei japanischen Patienten während von Nahrungsmittelherausforderungen zeigt, mit niedrigeren Symptomwerten innerhalb von 10 Minuten im Vergleich zu traditionellen Behandlungen.
Die Präsentationen werden umfassende klinische Forschungsdaten zeigen, einschließlich Studien zur Pharmakokinetik und Pharmakodynamik bei chinesischen Probanden, die die vergleichbare Wirksamkeit und Sicherheit von neffy im Vergleich zu intramuskulären Injektionen unter verschiedenen Bedingungen demonstrieren. Die Studien bestätigen die Wirksamkeit von neffy bei Kindern ab vier Jahren mit einem Gewicht von mehr als 15 Kilogramm.
neffy ist die erste und einzige von der FDA zugelassene nadelfreie Behandlung für Typ-I-Allergien, einschließlich Anaphylaxie, bei Erwachsenen und Kindern mit einem Gewicht von ≥30 kg (66 lbs). Die Veranstaltung findet vom 28. Februar bis 3. März 2025 in San Diego, Kalifornien, statt.
- First FDA-approved needle-free treatment for Type I allergic reactions
- Clinical data shows lower symptom scores within 10 minutes compared to traditional treatments
- Demonstrated comparable efficacy and safety to intramuscular injection
- Proven safe and effective for children four years or older weighing >15kg
- None.
Insights
The comprehensive data presentation at AAAAI 2025 significantly strengthens neffy's market position as the first FDA-approved needle-free anaphylaxis treatment. The clinical findings are particularly compelling in three key areas:
- The Japanese efficacy study demonstrates superior symptom control within 10 minutes compared to traditional treatments, addressing a critical need for rapid response in anaphylaxis management.
- Validation in Chinese populations confirms consistent pharmacokinetic and pharmacodynamic profiles across diverse ethnic groups, supporting global market potential.
- Expanded safety data in children ≥4 years weighing >15kg opens access to a important patient demographic, as pediatric applications often drive adoption in allergy treatments.
The needle-free delivery system represents a paradigm shift in anaphylaxis treatment. Current market penetration for traditional epinephrine auto-injectors is by needle anxiety and compliance issues. neffy's nasal spray format could significantly increase treatment adoption, particularly among pediatric patients and needle-phobic individuals.
The robust data package, covering various real-world conditions including self-administration, allergic rhinitis, and repeat dosing, addresses key clinical concerns that often impact prescriber confidence. This comprehensive validation across multiple patient populations and usage scenarios positions neffy to potentially capture significant market share in the global anaphylaxis treatment market.
Oral presentation on an efficacy study conducted in Japanese patients comparing anaphylaxis symptoms during oral food challenge with neffy as the initial treatment compared to site historical data on intramuscular auto-injectors, antihistamines and inhalers; patients receiving neffy had lower symptom scores within 10 minutes, supporting neffy as a needle-free option for management of anaphylaxis
neffy was shown to be in the safe and efficacious range for children four years or older who weigh more than 15 kilograms
Findings in Chinese studies confirms U.S. data and bracketed pharmacokinetic (PK) and pharmacodynamic (PD) profiles, demonstrate neffy’s comparable efficacy and safety under various conditions including self-administration, allergic rhinitis, infectious rhinitis, in allergy challenges and with repeat dosing, compared with intermuscular injection
SAN DIEGO, Feb. 18, 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 severe allergic reactions that could lead to anaphylaxis, announced today that nine presentations will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting, February 28 to March 3, in San Diego, California. The oral presentation and posters will feature data from a wide range of studies, including pharmacokinetics and pharmacodynamics of intranasal epinephrine under normal and various conditions, physiological responses between adults and children who are administered epinephrine, and the pre-treatment journey of patients with allergic conditions. In addition to the presentations, ARS Pharma will participate in and host a variety of onsite activities during the meeting.
“We look forward to sharing additional findings from our comprehensive clinical research program with the broader allergy community at AAAAI and expect that the data will continue to build on the existing robust data on the efficacy and safety of intranasal epinephrine administration,” said Sarina Tanimoto, MD, PhD, Co-Founder and Chief Medical Officer of ARS Pharma the maker of neffy (epinephrine nasal spray), the first and only FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). “As one of the leading companies actively conducting research in this critical space, we remain committed to advancing the scientific knowledge base of epinephrine so we can contribute to the allergy community.”
The complete list of presentations and meeting activities is below. Abstracts can be viewed at annualmeeting.aaaai.org. Attendees are encouraged to visit the ARS Pharma booth (#1315), oral and poster presentations as well as the product theatre to learn more about neffy.
| Oral Presentation – March 1, 2025 | |
| Time: | 2:45 p.m. - 2:55 p.m. PST |
| Title: | Superior Efficacy of Epinephrine Nasal Spray for the Relief of Symptoms Following an Oral Food Challenge |
| Speaker: | Kyohei Takahashi, MD, MPH, PhD |
| Room: | Convention Center, Upper Level, Room 6B |
| Poster ID: | 571 |
| Poster Presentations – March 1, 2025 | |
| Poster Presentation #1 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injections via HCP and Self-administration in Chinese Subjects Under Normal Conditions |
| Authors: | Yun Liu, MD, Shumin Wang, PhD, Miao Yu, MD, PhD, Pingya Hu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 297 |
| Poster Presentation #2 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Persistence to Treatment in Patients with Allergic Conditions Requiring Epinephrine Auto-Injector Prescription (EAI Rx) |
| Authors: | Autumn Burnette, MD, Raffi Tachdjian, MD, Nicole M. Chase, MD, Sarina Tanimoto, MD, PhD, Ayman Kafal, PhD, MPH |
| Poster ID: | 302 |
| Poster Presentation #3 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics of Epinephrine Nasal Spray under Various Conditions |
| Authors: | David M. Fleischer, MD, John Oppenheimer, MD, David Bernstein, MD, Thomas B. Casale, MD, Jonathan M. Spergel, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 290 |
| Poster Presentation #4 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Difference in Physiology Between Adults and Children in Response to Epinephrine Administration |
| Authors: | Matthew J. Greenhawt, MD, David M. Fleischer, MD, Thomas B. Casale, MD, Michael A. Kaliner, MD, Neetu Talreja, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 289 |
| Poster Presentation #5 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Understanding the Pre-Treatment Journey of Patients with Allergic Conditions: Insights from Patient Demographics and Diagnostic Pathways |
| Authors: | Raffi Tachdjian, MD, Autumn Burnette, MD, Nicole M. Chase, MD, Sarina Tanimoto, MD, PhD, Ayman Kafal, PhD, MPH |
| Poster ID: | 291 |
| Poster Presentation #6 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injection in Chinese Subjects Under Allergic Rhinitis Conditions |
| Authors: | Jianting Wang, MD, PhD, Shumin Wang, PhD, Miao Yu, MD, PhD, Jiaowei Lu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 318 |
| Poster Presentation #7 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Total Nasal Symptom Scores Remain Consistent in Response to Repeated Nasal Allergen Challenges |
| Authors: | Anne K. Ellis, MD, Michael A. Kaliner, MD, Carlos A. Camargo, Jr., MD, DrPH, John Oppenheimer, MD, David Bernstein, MD, Thomas B. Casale, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 483 |
| Poster Presentation #8 | |
| Time: | 9:45 a.m. - 10:45 a.m. PST |
| Title: | Pharmacokinetics and Pharmacodynamics of Repeat Dose of Epinephrine Nasal Spray and Manual Intramuscular Injection in Chinese Subjects Under Normal Conditions |
| Authors: | Shumin Wang, PhD, Jianting Wang, MD, PhD, Miao Yu, MD, PhD, Jiaowei Lu, MD, Richard Lowenthal, MSc, Sarina Tanimoto, MD, PhD |
| Poster ID: | 317 |
| Onsite Activities | |
| Joint Congress Opening Ceremony and Welcome Reception | |
| Date: | February 27, 2025 |
| Time: | 4:15 p.m. - 5:45 p.m. PST |
| Location: | Convention Center - Ground Level Room 6A |
| Non-CME Corporate Forum (Product Theatre) | |
| Date: | February 27, 2025 |
| Time: | 6:30 p.m. - 8:30 p.m. PST |
| Location: | Marriott Marquis San Diego Marina - North Tower, Lobby Level Grand Ballroom Salon 4 |
| Exhibit Booth | |
| Date: | February 28-March 2, 2025 |
| Location: | #1315 |
About neffy®
neffy is an intranasal epinephrine product for patients with Type I allergic reactions due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
IMPORTANT SAFETY INFORMATION
It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffy is for use in the nose only.
Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.
Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy should not deter use.
neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.
Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information on neffy, please see Full Prescribing Information at www.neffy.com.
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 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® 2 mg (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, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, 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.
ARS Pharma Investor Contact:
Justin Chakma
ARS Pharma
justinc@ars-pharma.com
ARS Pharma Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
FAQ
What are the key findings of neffy's efficacy study in Japanese patients (SPRY)?
What weight requirements exist for neffy (SPRY) treatment?
What conditions was neffy (SPRY) tested under in Chinese studies?
When will ARS Pharmaceuticals (SPRY) present their neffy data at AAAAI 2025?
