Aptar’s Nasal Unidose System to Deliver neffy® (epinephrine nasal spray), the First and Only FDA-Approved Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
AptarGroup, Inc. (NYSE: ATR) announced that its Unidose Liquid System is the delivery system approved for neffy® (epinephrine nasal spray), the first FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis. This marks the first worldwide regulatory approval for nasally-delivered epinephrine. Aptar's Unidose is a single-use, ready-to-use, one-step nasal delivery system that administers neffy during severe allergic reactions. The system's design promotes ease of use and adherence for patients and caregivers. Aptar Pharma Services supported the development process, helping to accelerate approval for this novel Combination Product submission.
AptarGroup, Inc. (NYSE: ATR) ha annunciato che il suo Unidose Liquid System è il sistema di somministrazione approvato per neffy® (spray nasale di epinefrina), il primo trattamento senza aghi approvato dalla FDA per le reazioni allergiche di tipo I, incluso l'anafilassi. Questo rappresenta la prima approvazione normativa a livello mondiale per l'epinefrina somministrata per via nasale. L'Unidose di Aptar è un sistema di somministrazione nasale monouso, pronto all'uso e a un passo che somministra neffy durante le gravi reazioni allergiche. Il design del sistema promuove la facilità d'uso e l'aderenza da parte dei pazienti e dei caregiver. I servizi farmaceutici di Aptar hanno supportato il processo di sviluppo, contribuendo ad accelerare l'approvazione per questa nuova presentazione di Prodotto Combinato.
AptarGroup, Inc. (NYSE: ATR) anunció que su Unidose Liquid System es el sistema de entrega aprobado para neffy® (aerosol nasal de epinefrina), el primer tratamiento sin aguja aprobado por la FDA para reacciones alérgicas tipo I, incluyendo anafilaxis. Esto marca la primera aprobación regulatoria mundial para la epinefrina administrada por vía nasal. El Unidose de Aptar es un sistema de entrega nasal de un solo uso, listo para usar y de un solo paso que administra neffy durante severas reacciones alérgicas. El diseño del sistema promueve la facilidad de uso y la adherencia para pacientes y cuidadores. Aptar Pharma Services apoyó el proceso de desarrollo, ayudando a acelerar la aprobación de esta nueva presentación de Producto Combinado.
AptarGroup, Inc. (NYSE: ATR)는 Unidose Liquid System이 neffy® (에피네프린 비강 스프레이)에 대해 승인된 전달 시스템이라는 것을 발표했습니다. 이는 FDA에서 승인한 첫 바늘 없는 제1형 알레르기 반응 치료제이며, 아나필락시스를 포함합니다. 이는 비강을 통해 전달되는 에피네프린에 대한 세계 최초의 규제 승인입니다. Aptar의 Unidose는 심각한 알레르기 반응 중에 neffy를 투여하는 단일 사용, 즉시 사용 가능, 원스텝 비강 전달 시스템입니다. 시스템의 디자인은 환자와 돌보는 사람들을 위한 사용의 용이성과 순응성을 촉진합니다. Aptar Pharma Services는 개발 과정을 지원하여 이 새로운 복합 제품 제출의 승인을 가속화하는 데 도움을 주었습니다.
AptarGroup, Inc. (NYSE: ATR) a annoncé que son Unidose Liquid System est le système de délivrance approuvé pour neffy® (spray nasal d'épinéphrine), le premier traitement sans aiguille approuvé par la FDA pour les réactions allergiques de type I, y compris l'anaphylaxie. Cela marque la première approbation réglementaire mondiale pour l'épinéphrine administrée par voie nasale. Le système Unidose d'Aptar est un système de délivrance nasale à usage unique, prêt à l'emploi et facile d'utilisation qui administre neffy pendant de graves réactions allergiques. Le design du système favorise la facilité d'utilisation et l'observance pour les patients et les aidants. Les services pharmaceutiques d'Aptar ont soutenu le processus de développement, contribuant à accélérer l'approbation de cette nouvelle soumission de Produit Combiné.
AptarGroup, Inc. (NYSE: ATR) gab bekannt, dass ihr Unidose Liquid System das genehmigte Abgabesystem für neffy® (Epinephrin-Nasenspray) ist, die erste von der FDA zugelassene nadelfreie Behandlung für Typ-I-Allergiereaktionen, einschließlich Anaphylaxie. Dies stellt die erste weltweite regulatorische Zulassung für nasale Epinephrinabgabe dar. Aptars Unidose ist ein Einmalgebrauch, sofort einsatzbereites, ein Schritt Nasenausgabesystem, das neffy während schwerer allergischer Reaktionen verabreicht. Das Design des Systems fördert die Benutzerfreundlichkeit und die Einhaltung durch Patienten und Pflegepersonen. Aptar Pharma Services unterstützte den Entwicklungsprozess und half, die Genehmigung für diese neuartige Kombination zu beschleunigen.
- First FDA approval for nasally-delivered epinephrine treatment
- Potential market expansion for Aptar's Unidose Liquid System
- Demonstrates Aptar's leadership in nasal drug delivery technology
- Accelerated development support through Aptar Pharma Services
- None.
Insights
The FDA approval of neffy® using Aptar's Unidose Liquid System marks a significant advancement in anaphylaxis treatment. This needle-free, nasal spray delivery method could revolutionize emergency care for severe allergic reactions. The single-use, ready-to-use design simplifies administration, potentially reducing user error in high-stress situations.
From a medical device perspective, Aptar's system addresses key challenges in epinephrine delivery: ease of use, portability and rapid administration. The nasal route may offer advantages over traditional auto-injectors, including faster absorption and reduced anxiety for needle-phobic patients. However, factors like nasal congestion could affect efficacy, warranting further real-world studies.
This approval could spark a shift in the
Aptar's collaboration with ARS Pharmaceuticals on neffy® demonstrates the company's strong position in drug delivery innovation. This FDA approval validates Aptar's Unidose technology and could lead to increased adoption across the pharmaceutical industry for various medications.
The market impact could be substantial. With over 32 million Americans at risk for anaphylaxis, neffy® could capture a significant portion of the epinephrine market. Aptar's revenue from this product line could see notable growth, especially if international approvals follow.
Importantly, Aptar's comprehensive services, from formulation to regulatory support, showcase its end-to-end capabilities. This integrated approach could attract more pharmaceutical partnerships, potentially driving long-term growth across Aptar's portfolio. Investors should monitor adoption rates and any expansion into other emergency medications or therapeutic areas using this delivery system.
The approval of neffy® is a game-changer for patients at risk of anaphylaxis. The needle-free design addresses a significant barrier to treatment - fear of needles, which affects up to
The intuitive, one-step application process of Aptar's Unidose system may reduce the risk of user error, a critical factor when every second counts during an allergic reaction. Additionally, the nasal spray format could make it easier for bystanders to assist in emergencies, potentially expanding the network of people able to provide life-saving treatment.
However, patient education will be crucial. Users must understand the differences between nasal and injector administration, including proper technique and potential limitations. Overall, this innovation represents a significant step forward in patient-centric design for emergency medications.
Photo: Aptar’s Unidose System for the neffy® 2 mg (epinephrine nasal spray). Image courtesy of ARS Pharmaceuticals.
Aptar’s Unidose is a single-use, ready-to-use, one-step nasal delivery system used to administer neffy to a patient during a severe allergic reaction. During such an event, the patient, healthcare professional, caregiver or user presses a small plunger on the bottom of the nasal spray system to release the drug in a single spray into the nostril.
Stephan B. Tanda, Aptar President and CEO, stated, “Aptar has been a leader in nasal delivery of medication for more than 30 years. We are proud of our role in the pharma industry to increase the use of nasally delivered medications that help promote adherence and ease of use for patients.”
Unidose (UDS) and Bidose (BDS) Technology Platforms
Aptar’s UDS and BDS technology platforms are designed to be robust, reliable and intuitive systems for easy administration by patients or caretakers. These drug delivery systems are designed and manufactured with strict quality controls intended to meet FDA’s guidelines for reliability. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including for emergency use and treatments of severe conditions. They can also be integrated with wireless connectivity technologies.
Accelerated Development Support via Aptar Pharma Services
This novel treatment for severe allergic reaction is an example of a Combination Product submission, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to help accelerate approval.
“The approval of neffy, which uses our Unidose System, and is the first nasally-delivered epinephrine treatment for severe allergic reaction, including anaphylaxis, once again demonstrates Aptar Pharma’s ‘formulation to patient’ focus on helping our customers develop complex, innovative treatments,” stated Gael Touya, President, Aptar Pharma. “When we combine our nasal systems’ capabilities with our Aptar Pharma Services offering, we bring added value to our customers, and aim to provide further convenience for patients and their caregivers worldwide.”
About Aptar
Aptar Pharma is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in
About ARS Pharmaceuticals
ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis. The company is commercializing neffy®, an epinephrine nasal spray product for patients with Type I allergic reactions, including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.
This press release contains forward-looking statements. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Forms 10-Q. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.
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Aptar Investor Relations Contact:
Mary Skafidas
+1 347 351 6407
mary.skafidas@aptar.com
Aptar Pharma Media Contact:
Carolyn Penot
+33 6 37 36 76 84
carolyn.penot@aptar.com
Aptar Media Contact:
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+1 815 479 5671
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Source: AptarGroup, Inc.
FAQ
What is neffy® and how is it delivered using Aptar's technology?
How does Aptar's Unidose System for neffy® benefit patients with severe allergies?
What impact might the approval of neffy® have on Aptar's (ATR) market position?
How did Aptar Pharma Services contribute to the approval of neffy®?
