ARS Pharmaceuticals Showcases Intranasal Epinephrine Data at 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
ARS Pharmaceuticals (Nasdaq: SPRY) announced the presentation of seven abstracts at the 2024 ACAAI Annual Scientific Meeting in Boston. The presentations focus on their product neffy®, the first needle-free intranasal epinephrine spray for Type I allergic reactions and anaphylaxis. The abstracts cover various aspects including cardiovascular safety, human factor studies, and real-world administration data in pediatric patients. The research demonstrates that nasal spray delivery of epinephrine is successfully administered in real-world situations and provides insights into epinephrine's mechanism of action. The presentations are scheduled for October 25, with topics ranging from pharmacokinetics to healthcare provider interest in the intranasal device.
ARS Pharmaceuticals (Nasdaq: SPRY) ha annunciato la presentazione di sette abstract nel 2024 ACAAI Annual Scientific Meeting a Boston. Le presentazioni si concentrano sul loro prodotto neffy®, il primo spray intranasale di epinefrina senza ago per reazioni allergiche di Tipo I e anafilassi. Gli abstract trattano vari aspetti tra cui la sicurezza cardiovascolare, studi sui fattori umani e dati sull'uso pratico nei pazienti pediatrici. La ricerca dimostra che la somministrazione di epinefrina tramite spray nasale è stata effettuata con successo in situazioni reali e fornisce approfondimenti sul meccanismo d'azione dell'epinefrina. Le presentazioni sono programmate per il 25 ottobre, con argomenti che spaziano dalla farmacocinetica all'interesse degli operatori sanitari per il dispositivo intranasale.
ARS Pharmaceuticals (Nasdaq: SPRY) anunció la presentación de siete resúmenes en la Reunión Científica Anual ACAAI 2024 en Boston. Las presentaciones se centran en su producto neffy®, el primer spray intranasal de epinefrina sin aguja para reacciones alérgicas de Tipo I y anafilaxis. Los resúmenes cubren varios aspectos, incluyendo la seguridad cardiovascular, estudios de factores humanos y datos de administración en la vida real en pacientes pediátricos. La investigación demuestra que la entrega de epinefrina a través de spray nasal se administra con éxito en situaciones reales y proporciona información sobre el mecanismo de acción de la epinefrina. Las presentaciones están programadas para el 25 de octubre, con temas que van desde la farmacocinética hasta el interés de los proveedores de salud en el dispositivo intranasal.
ARS 제약회사 (Nasdaq: SPRY)는 2024 ACAAI 연례 과학 회의에서 7개의 초록을 발표한다고 발표했습니다. 발표는 제품 neffy®에 초점을 맞추고 있으며, 이는 제1형 알레르기 반응 및 아나필락시스를 위한 첫 번째 비주사형 비강 에피네프린 스프레이입니다. 초록은 심혈관 안전성, 인간 요인 연구 및 소아 환자에서의 실제 사용 데이터 등 다양한 측면을 다룹니다. 연구 결과, 비강 스프레이를 통한 에피네프린 전달이 실제 상황에서 성공적으로 시행되었으며 에피네프린의 작용 메커니즘에 대한 통찰력을 제공합니다. 발표는 10월 25일로 예정되어 있으며, 주제는 약물동태학에서부터 비강 장치에 대한 의료 제공자의 관심까지 다양합니다.
ARS Pharmaceuticals (Nasdaq: SPRY) a annoncé la présentation de sept résumés lors de la Réunion Scientifique Annuelle de l'ACAAI 2024 à Boston. Les présentations portent sur leur produit neffy®, le premier spray intranasal d'épinéphrine sans aiguille pour les réactions allergiques de type I et l'anaphylaxie. Les résumés couvrent divers aspects, notamment la sécurité cardiovasculaire, des études sur les facteurs humains et des données sur l'administration en conditions réelles chez les patients pédiatriques. La recherche démontre que l'administration d'épinéphrine par spray nasal est réalisée avec succès dans des situations réelles et offre un aperçu du mécanisme d'action de l'épinéphrine. Les présentations sont prévues pour le 25 octobre et traitent de sujets allant de la pharmacocinétique à l'intérêt des prestataires de soins de santé pour l'appareil intranasal.
ARS Pharmaceuticals (Nasdaq: SPRY) hat die Präsentation von sieben Abstracts auf dem 2024 ACAAI Annual Scientific Meeting in Boston angekündigt. Die Präsentationen konzentrieren sich auf ihr Produkt neffy®, das erste nadelfreie intranasale Epinephrin-Spray für Typ-I-Allergien und Anaphylaxie. Die Abstracts decken verschiedene Aspekte ab, einschließlich der kardiovaskulären Sicherheit, menschliche Faktorenstudien und Daten zur Anwendung in der realen Welt bei pädiatrischen Patienten. Die Forschung zeigt, dass die Verabreichung von Epinephrin über ein Nasenspray in realen Situationen erfolgreich erfolgt und Einblicke in den Wirkmechanismus von Epinephrin bietet. Die Präsentationen sind für den 25. Oktober geplant, mit Themen, die von Pharmakokinetik bis zum Interesse von Gesundheitsdienstleistern an dem intranasalen Gerät reichen.
- First and only FDA-approved needle-free epinephrine treatment for allergic reactions
- Successful real-world administration data supporting product efficacy
- Multiple clinical studies demonstrating product safety and effectiveness
- None.
Insights
The presentation of seven abstracts at ACAAI represents significant scientific validation for ARS Pharmaceuticals' neffy® nasal spray. The research covers important aspects including cardiovascular safety, pharmacokinetics and real-world administration data in pediatric patients.
Key findings demonstrate that intranasal epinephrine delivery is not only effective but also provides valuable insights into the drug's mechanism of action. The studies address critical aspects like blood pressure responses, pulse rate changes and successful administration with a two-dose carrying case. This comprehensive data package strengthens neffy®'s position as the first needle-free epinephrine treatment for Type I allergic reactions.
The breadth and depth of research presented suggest strong clinical validation, which could positively influence market adoption among healthcare providers and patients. The focus on real-world data and practical aspects like the two-dose carrying case indicates a well-rounded approach to product development and commercialization.
SAN DIEGO, Oct. 24, 2024 (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 seven abstracts will be featured tomorrow, Friday, October 25 at the 2024 ACAAI Annual Scientific Meeting taking place in Boston, Massachusetts. The posters highlight a wide range of studies focused on intranasal epinephrine administration, including cardiovascular safety, human factor study of carrying two devices at all times, and real-world administration data in pediatric patients.
“The research being presented at the ACAAI Annual Scientific Meeting is part of the extensive body of knowledge that ARS has contributed on epinephrine administration through our comprehensive clinical research,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals, the developer of neffy® (epinephrine nasal spray) the first and only needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). “Our studies have brought forward valuable new data that demonstrates nasal spray delivery of epinephrine is not only successfully administered in real-world situations, but it also provides valuable insights into the broader understanding of how epinephrine works in the body. Our research contributes to the allergy community’s knowledge of both neffy’s performance and expands scientific findings and hypothesis, helping us advance treatment options for patients with severe allergies.”
The complete list of ARS Pharmaceuticals’ poster presentations is below. Full posters can be viewed online here.
| Poster Presentation #1 | |
| Time: | 3:15-3:30pm EDT |
| Title: | “Cardiovascular Safety of Intramuscular and Intranasal Epinephrine Administration” |
| Authors: | Jay A. Lieberman, Richard D Wainford, Carlos A. Camargo Jr, Thomas B Casale, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8064 |
| ePoster ID: | R235 |
| Poster Presentation #2 | |
| Time: | 3:30-3:45pm EDT |
| Title: | “Blood Pressure And Pulse Rate Increases, Without Concomitant Epinephrine Increases, During Acute Allergic Reactions” |
| Authors: | Jonathan M. Spergel, Motohiro Ebisawa, Anne K. Ellis, Thomas B. Casale, John Oppenheimer, Carlos A. Camargo, Jr., Aikaterini Anagnostou, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8065 |
| ePoster ID: | R236 |
| Poster Presentation #3 | |
| Time: | 3:45-4:00pm EDT |
| Title: | “Successful Administration of ARS-1 (Intranasal Epinephrine) when Provided with a Two-Dose Carrying Case-Human Factor Study” |
| Authors: | Vivian Hernandez-Trujillo, Joel Brooks, Raffi Tachdjian, Brian Dorsey, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8066 |
| ePoster ID: | R237 |
| Poster Presentation #4 | |
| Time: | 4:00-4:15pm EDT |
| Title: | “Significant Differences in Pharmacokinetic Profiles Among Epinephrine Products-What is the Mechanism for Efficacy?” |
| Authors: | Matthew Greenhawt, Jay A Lieberman, Thomas B. Casale, Anna Nowak-Wegrzyn, Jonathan M. Spergel, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8067 |
| ePoster ID: | R238 |
| Poster Presentation #5 | |
| Time: | 4:15-4:30pm EDT |
| Title: | “Pharmacokinetics And Pharmacodynamics Following Repeat Dosing of ARS-1 versus Intramuscular Injection During Allergic Rhinitis” |
| Authors: | John Oppenheimer, Thomas Casale, Jonathan Spergel, David Bernstein, Carlos A. Camargo, Jr., Anne Ellis, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8068 |
| ePoster ID: | R239 |
| Poster Presentation #6 | |
| Time: | 4:30-4:45pm EDT |
| Title: | “ARS-1 Development, From Pharmacokinetics and Pharmacodynamics to Real-World Data in Pediatric Food Allergy Patients” |
| Authors: | Motohiro Ebisawa, David M. Fleischer, H Henry Li, Michael Kaliner, Richard Lockey, Neetu Talreja, Richard Lowenthal, Sarina Tanimoto |
| Abstract ID: | 8069 |
| ePoster ID: | R240 |
| Poster Presentation #7 | |
| Time: | 4:45-5:00pm EDT |
| Title: | “HCP Interest in ARS-1, a Self-Administered Intranasal Epinephrine Device” |
| Authors: | Nicole Chase, Autumn Burnette, Daniel Soteres, Justin Greiwe, Harris Kaplan, Ayman Kafal |
| Abstract ID: | 8070 |
| ePoster ID: | R241 |
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 due to food, venom or insect stings. Of those, only 3.3 million currently have an 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 neffy®
neffy® is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites 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 ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is 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. 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 US 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 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 significance of the results from ARS Pharmaceuticals’ studies; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer epinephrine; the potential market and demand for neffy; 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 “can,” “could,” “may,” “potential,” “will,” 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: the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for 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 June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents ARS Pharmaceuticals files with the SEC can also be accessed on ARS Pharmaceuticals’ website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
Alex Straus
THRUST Strategic Communications
alex@thrustsc.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
FAQ
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