Aquestive Therapeutics Advances Global Regulatory Strategy for Anaphylm Epinephrine Sublingual Film
Key Insights
Aquestive Therapeutics is expanding Anaphylm's regulatory pathway globally, planning submissions to Health Canada in the first half of 2026 and Europe in the second half of 2026.
The European Medicines Agency (search) provided positive feedback indicating no additional clinical trials are needed prior to regulatory approval submission for the sublingual epinephrine film.
The company maintains approximately $120 million in cash and cash equivalents, which management believes is sufficient to complete Anaphylm approval and launch processes in the U.S. while advancing international markets.
Aquestive Therapeutics is accelerating its global expansion strategy for Anaphylm, its investigational sublingual epinephrine film for severe allergic reactions (search) including anaphylaxis (search), with regulatory submissions planned across multiple international markets in 2025 and 2026.
International Regulatory Milestones
The company announced plans to initiate regulatory engagements in Canada, Europe, and the United Kingdom in 2025. Aquestive expects to submit its New Drug Submission (NDS) to Health Canada in the first half of 2026, followed by a marketing authorization application in Europe in the second half of 2026.
A significant regulatory milestone came from the European Medicines Agency (search) (EMA), which provided positive feedback indicating that no further clinical trials are needed prior to regulatory approval submission. This feedback could streamline the European approval pathway for the novel epinephrine delivery system.
The company also expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in the first quarter of 2026, representing another key regulatory touchpoint in the global expansion strategy.
Novel Epinephrine Delivery Technology
Anaphylm (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate that offers a non-invasive alternative to traditional epinephrine auto-injectors. The sublingual film is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact without requiring water or swallowing for administration.
The primary packaging for Anaphylm is designed to be thinner and smaller than an average credit card, allowing it to be carried in a pocket while withstanding weather excursions such as exposure to rain and sunlight. The FDA has conditionally approved the Anaphylm trade name for AQST-109, with final approval of the proprietary name conditioned on FDA approval of the product candidate.
Commercial Preparation and Financial Position
As previously planned, Aquestive intends to hire its U.S. sales force following FDA approval and continues to advance other pre-commercial activities for Anaphylm. The company's goal focuses on addressing critical unmet needs in severe allergy management by bringing what could be the first and only orally delivered epinephrine product to market.
Aquestive ended 2025 with approximately $120 million in cash and cash equivalents. Company management continues to believe this funding is sufficient to complete the Anaphylm approval and launch processes in the U.S., if approved by the FDA, while progressing Anaphylm development in other key markets outside the U.S.
Addressing Unmet Medical Needs
The global expansion strategy underscores Aquestive's commitment to providing patients with an innovative treatment option for severe allergic reactions (search). In both the U.S. and international markets, the company aims to offer the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis (search), if approved by the respective regulatory authorities in these jurisdictions.
The regulatory progress represents important opportunities to expand access to the company's non-invasive epinephrine therapy globally, potentially transforming how patients and caregivers manage severe allergic emergencies across multiple healthcare systems.