Aquestive Therapeutics Provides International Expansion Update for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics (NASDAQ: AQST) has announced significant progress in its international expansion for Anaphylm™, its needle-free epinephrine sublingual film for severe allergic reactions. The company has secured a New Drug Submission meeting with Health Canada for Q3 2025 and submitted an initial briefing book to the European Medicines Agency (EMA).
These developments follow the FDA's acceptance of Anaphylm's New Drug Application with a PDUFA date of January 31, 2026. Aquestive brings substantial experience with six FDA-approved drugs and products available across six continents. The oral administration of Anaphylm addresses key challenges of traditional auto-injectors, including needle phobia and device malfunction concerns.
Aquestive Therapeutics (NASDAQ: AQST) ha annunciato progressi significativi nella sua espansione internazionale per Anaphylm™, il suo film sublinguale di epinefrina senza ago per reazioni allergiche gravi. L'azienda ha ottenuto un incontro per la presentazione di una nuova domanda di farmaco con Health Canada previsto per il terzo trimestre del 2025 e ha inviato un primo dossier informativo all'Agenzia Europea per i Medicinali (EMA).
Questi sviluppi seguono l'accettazione da parte della FDA della New Drug Application di Anaphylm con una data PDUFA fissata per il 31 gennaio 2026. Aquestive vanta una solida esperienza con sei farmaci approvati dalla FDA e prodotti disponibili in sei continenti. La somministrazione orale di Anaphylm risolve le principali problematiche degli auto-iniettori tradizionali, come la paura degli aghi e i rischi di malfunzionamento del dispositivo.
Aquestive Therapeutics (NASDAQ: AQST) ha anunciado avances significativos en su expansión internacional para Anaphylm™, su película sublingual de epinefrina sin aguja para reacciones alérgicas graves. La compañía ha asegurado una reunión para la presentación de un nuevo medicamento con Health Canada para el tercer trimestre de 2025 y ha enviado un primer dossier informativo a la Agencia Europea de Medicamentos (EMA).
Estos avances siguen a la aceptación por parte de la FDA de la solicitud de nuevo medicamento de Anaphylm con una fecha PDUFA del 31 de enero de 2026. Aquestive aporta una amplia experiencia con seis medicamentos aprobados por la FDA y productos disponibles en seis continentes. La administración oral de Anaphylm aborda los principales desafíos de los autoinyectores tradicionales, incluyendo la fobia a las agujas y las preocupaciones sobre fallos del dispositivo.
Aquestive Therapeutics (NASDAQ: AQST)는 중증 알레르기 반응을 위한 바늘 없는 에피네프린 설하 필름인 Anaphylm™의 국제적 확장에 있어 중요한 진전을 발표했습니다. 회사는 2025년 3분기에 Health Canada와의 신약 제출 회의를 확보했으며, 유럽 의약품청(EMA)에 초기 브리핑 자료를 제출했습니다.
이러한 발전은 FDA가 Anaphylm의 신약 신청을 승인하고 2026년 1월 31일 PDUFA 날짜를 지정한 데 따른 것입니다. Aquestive는 6개의 FDA 승인 약물과 6개 대륙에 걸친 제품들을 보유한 풍부한 경험을 가지고 있습니다. Anaphylm의 경구 투여 방식은 바늘 공포증과 기기 오작동 문제 등 전통적인 자동 주입기의 주요 문제를 해결합니다.
Aquestive Therapeutics (NASDAQ: AQST) a annoncé des progrès significatifs dans son expansion internationale pour Anaphylm™, son film sublingual d'épinéphrine sans aiguille destiné aux réactions allergiques sévères. La société a obtenu une réunion de soumission de nouveau médicament avec Santé Canada prévue pour le troisième trimestre 2025 et a soumis un premier dossier d'information à l'Agence européenne des médicaments (EMA).
Ces avancées font suite à l'acceptation par la FDA de la demande de nouveau médicament pour Anaphylm, avec une date PDUFA fixée au 31 janvier 2026. Aquestive bénéficie d'une solide expérience avec six médicaments approuvés par la FDA et des produits disponibles sur six continents. L'administration orale d'Anaphylm répond aux principaux défis des auto-injecteurs traditionnels, notamment la peur des aiguilles et les risques de dysfonctionnement des dispositifs.
Aquestive Therapeutics (NASDAQ: AQST) hat bedeutende Fortschritte bei seiner internationalen Expansion für Anaphylm™ bekannt gegeben, einen nadelfreien epinephrinhaltigen sublingualen Film für schwere allergische Reaktionen. Das Unternehmen hat ein Treffen zur Einreichung eines neuen Arzneimittels bei Health Canada für das dritte Quartal 2025 gesichert und ein erstes Informationsdossier bei der Europäischen Arzneimittelagentur (EMA) eingereicht.
Diese Entwicklungen folgen auf die Annahme des New Drug Application von Anaphylm durch die FDA mit einem PDUFA-Termin am 31. Januar 2026. Aquestive bringt umfangreiche Erfahrung mit sechs von der FDA zugelassenen Medikamenten und Produkten, die auf sechs Kontinenten verfügbar sind. Die orale Verabreichung von Anaphylm löst wesentliche Herausforderungen herkömmlicher Autoinjektoren, wie Nadelphobie und Bedenken hinsichtlich Gerätefehlern.
- FDA has already accepted New Drug Application with PDUFA date set for January 31, 2026
- Secured regulatory meeting with Health Canada for Q3 2025
- Initial briefing book submitted to European Medicines Agency
- Company has strong track record with 6 FDA-approved drugs and global presence
- Product addresses key limitations of current epinephrine auto-injectors
- Timeline for potential EMA approval remains uncertain
- International regulatory processes could face delays or setbacks
Insights
Aquestive's international expansion of Anaphylm shows promising regulatory progress toward potential global commercialization of their needle-free epinephrine delivery system.
Aquestive's international regulatory progress for Anaphylm represents a strategic expansion of their approval pathway beyond the U.S. market. The scheduled Health Canada meeting and EMA briefing book submission indicate the company is executing a parallel regulatory strategy rather than a sequential approach, which could accelerate time-to-market across multiple jurisdictions.
What's particularly noteworthy is the timing of these international initiatives. With the FDA already having accepted their NDA and established a PDUFA date of January 31, 2026, Aquestive appears to be leveraging their U.S. regulatory package to expedite international submissions. This approach is efficient and suggests confidence in their clinical data package.
The sublingual film delivery system for epinephrine addresses several critical limitations of traditional auto-injectors: needle phobia (which affects approximately 10% of the population), concerns about device malfunctions, and portability challenges that impact patient compliance. These barriers contribute to undertreatment of anaphylaxis, which affects approximately
From a regulatory perspective, Aquestive's claim of six FDA-approved drugs and presence across six continents demonstrates established regulatory expertise that will be valuable in navigating different jurisdictional requirements. The selection of Canada and Europe as initial ex-U.S. targets is strategically sound given their well-defined regulatory pathways for innovative drug delivery systems and substantial addressable patient populations.
The company's emphasis on markets with regulatory frameworks "conducive to innovative therapies" suggests they're prioritizing regions where novel delivery mechanisms may receive more favorable or expedited review consideration, potentially accelerating approval timelines compared to more conservative regulatory environments.
- New Drug Submission meeting scheduled with Health Canada for the third quarter of 2025
- Initial briefing book submitted for review to the European Medicines Agency
WARREN, N.J., July 15, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that Health Canada has granted the Company a meeting to discuss Aquestive’s planned New Drug Submission (NDS) for Anaphylm™ (epinephrine) Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency (EMA). The Company plans to submit a Marketing Authorization Application (MAA) to the EMA as soon as possible.
“These regulatory activities mark the pivotal first steps in Aquestive’s comprehensive ex-U.S. regulatory strategy,” said Dan Barber, President and Chief Executive Officer of Aquestive. “With our U.S. FDA New Drug Application recently accepted and a PDUFA target action date of January 31, 2026 established, we’re now positioned to pursue parallel regulatory pathways with the potential to bring needle-free, device-free Anaphylm to patients underserved by current treatment options. Our proven ability to successfully bring innovative therapies to market globally, combined with our oral epinephrine approach, positions us to fundamentally change how patients and caregivers manage severe allergic reactions, including anaphylaxis.”
Aquestive brings significant regulatory and commercialization experience to this expansion effort, with six FDA-approved drugs in its portfolio and products currently available across six continents. This established global footprint and regulatory track record positions the Company to efficiently navigate international approval processes.
Unlike traditional epinephrine auto-injectors that require needles, Anaphylm™ is administered orally, addressing critical barriers to treatment, including needle phobia, device malfunction concerns, and portability challenges that affect patient compliance and emergency response.
The Company’s ex-U.S. regulatory strategy prioritizes markets with significant unmet medical needs and regulatory frameworks conducive to innovative therapies. EMA and Canada represent ideal initial international markets given their collaborative regulatory environment and substantial population of patients requiring reliable anaphylaxis treatment options.
Aquestive will continue to provide updates on its global regulatory approval progress as it works to establish Anaphylm as the new standard of care for the treatment of severe allergic reactions and anaphylaxis worldwide.
About Anaphylm™ (epinephrine) Sublingual Film
Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the U.S. Food and Drug Administration (FDA). Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for possible various dermatology conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn.
Forward-Looking Statement
Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA, Health Canada and EMA; the expected plans for regulatory approval and commercialization of Anaphylm in markets outside of the United States, if approved by the applicable regulatory authorities, including in Canada and the European Union; the advancement of the Company’s product candidate AQST-108 through clinical development and approval by the FDA for possible various dermatology conditions including alopecia areata; the potential benefits our products and product candidates could bring to patients; and business strategies, market opportunities, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including with respect to the approval of our filed NDA for Anaphylm, or the failure to receive FDA approval at all for any of our product candidates, including Anaphylm and AQST-108; risk of the Company’s ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments on the Company’s clinical trials and other concerns identified in the FDA’s Type C meeting minutes and filing review letter for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk that the FDA may require that an Advisory Committee be required for the approval of Anaphylm and that the Company is able to address any concerns raised by such Advisory Committee or the FDA after review of the advice from the Advisory Committee; risk of delays in advancement of the regulatory approval process outside the U.S. of our product candidates, including Anaphylm in Canada and the European Union; risk of the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund commercialization activities relating to fund future clinical development and commercial activities for our product candidates, including Anaphylm and AQST-108, should these product candidates be approved by the FDA, Health Canada and EMA; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in and outside of the U.S. of Anaphylm and our other product candidates, should these product candidates be approved by the FDA, Health Canada and EMA, and for our licensed products in the U.S. and abroad; risk of the size and growth of our product markets; risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office (USPTO); risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and products candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against Aquestive including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and rising interest rates; risks related to the impact of the COVID-19 global pandemic and other pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions; risks related to uncertainties about U.S. government initiatives and their impact on our business, including imposition of tariffs and other trade restrictions; and other unusual items; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.
PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.
Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com
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