WARREN, N.J., October 15, 2026
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, an investigational treatment for Type I allergic reactions, including anaphylaxis. The FDA determined that the resubmission was complete and classified it as a Class 2 response, establishing a Prescription Drug User Fee Act (PDUFA) goal action date of March 16, 2027. Aquestive resubmitted the application on September 16, 2026, following positive topline results from human factors and pharmacokinetic studies announced in August 2026. Those studies were conducted to address items identified in an FDA Complete Response Letter dated January 30, 2026. If approved, Anaphylm would be the first oral rescue medication for severe allergic reactions, including anaphylaxis, according to the company. The acceptance marks a further regulatory milestone for Aquestive as it continues preparations for a potential U.S. launch while advancing its international regulatory strategy. The company also confirmed that it remains on track to submit a New Drug Submission (NDS) to Health Canada in the fourth quarter of 2026.
FDA Review Sets March 2027 Decision Target
The FDA’s acceptance of the Anaphylm NDA resubmission establishes the next stage of regulatory review for the investigational product. The agency assigned a Class 2 review classification and a PDUFA goal date of March 16, 2027. Aquestive initially submitted the resubmission on September 16, 2026, after completing human factors and pharmacokinetic studies intended to address deficiencies identified in the January 2026 Complete Response Letter. The company reported positive topline results from these studies in August 2026. Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics, said the FDA’s acceptance provides a defined path forward for the program. He emphasized the company’s objective of developing a rescue treatment that patients and caregivers can carry and use confidently in everyday settings, including schools, workplaces and while traveling. The company plans to continue working with the FDA throughout the review process and is preparing for a potential commercial launch, subject to approval. Acceptance of a resubmission does not mean the FDA has approved the product; the agency will evaluate the application before making its decision. The March 16, 2027 date is the FDA’s target action date rather than a guarantee of approval or commercial availability.
Sublingual Film Designed for Emergency Allergy Treatment
Anaphylm is a polymer matrix-based sublingual film containing dibutepinephrine, an epinephrine prodrug, being developed to treat Type I allergic reactions, including anaphylaxis. The product is designed to dissolve upon contact without requiring water or swallowing. According to Aquestive, the film is approximately the size of a postage stamp and weighs less than one ounce. Its packaging is designed to be thinner and smaller than an average credit card, allowing it to fit in a wallet or phone-carrying setup. The company also states that the packaging is designed to withstand environmental exposure, including rain and sunlight. These features are intended to support portability and ease of use when a severe allergic reaction requires urgent treatment. If approved, Anaphylm would offer a different delivery format from conventional injectable epinephrine products. However, its potential role in emergency treatment will depend on the FDA’s assessment of its safety, effectiveness, usability and labeling. The Anaphylm trade name for candidate AQST-109 has received conditional FDA approval, with final approval of the proprietary name contingent on approval of the product itself. Until regulatory authorization is granted, Anaphylm remains investigational and should not be considered an approved replacement for currently authorized emergency treatments.
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International Strategy and Commercial Preparations
Alongside its U.S. regulatory review, Aquestive continues to advance its plans for international development. The company said it remains on track to complete a New Drug Submission to Health Canada in Q4 2026. In parallel, it is preparing for a possible U.S. launch if the FDA approves Anaphylm. Aquestive develops medicines using proprietary drug-delivery technologies, with a particular focus on oral film formulations. The company operates its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana, and it manufactures four commercialized products marketed by licensees across six continents. Its development portfolio includes Anaphylm for severe allergic reactions and AQST-108, an epinephrine topical gel being investigated for potential dermatological applications. The company’s AdrenaVerse platform contains a library of more than 20 epinephrine prodrugs intended to support research across potential allergy and dermatology indications. The FDA’s acceptance of the Anaphylm resubmission advances the candidate toward a regulatory decision, while the planned Canadian submission would extend its regulatory pathway beyond the United States. The next major milestone is the FDA’s review of the resubmitted NDA, with the outcome determining whether the product can proceed to commercialization.
Source::Aquestive Therapeutics press release
