WARREN, N.J. — September 17, 2026
Aquestive Therapeutics announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis. The resubmission follows the FDA’s Complete Response Letter (CRL) issued January 30, 2026, which requested additional human factors and pharmacokinetic studies addressing product packaging, administration and drug exposure. Aquestive said the resubmission incorporates data from completed studies supporting revised packaging and instructions for use. The FDA will determine the classification of the resubmission and establish the applicable review timeline following its initial assessment.
Human Factors Study Supports Revised Anaphylm Packaging
Aquestive completed a human factors study evaluating redesigned Anaphylm packaging and administration instructions in response to the FDA’s CRL. The updated design included modifications to the pouch opening, instructions for use, and pouch and carton labeling. The company reported that the revised packaging reduced median pouch-opening time from 17 seconds to 3 seconds, addressing a key usability component for a product intended for emergency treatment. Aquestive also completed a confirmatory PK study in healthy volunteers using the revised packaging and instructions. The study evaluated both self-administration and clinician administration of Anaphylm and included manual intramuscular epinephrine as a comparator. According to the company, no protocol-defined use errors occurred in the self-administration arm, providing additional human factors data for the resubmitted application.
Anaphylm Designed as Needle-Free Epinephrine Option
Anaphylm is an investigational sublingual film based on a polymer matrix-based epinephrine prodrug, designed to provide a compact and needle-free alternative for emergency treatment of severe allergic reactions. The film is approximately the size of a postage stamp, weighs less than an ounce and begins dissolving upon contact without requiring water or swallowing. Its primary packaging is designed to be thinner and smaller than an average credit card and suitable for carrying in a pocket. Previous clinical studies reported rapid pharmacodynamic responses, including increases in heart rate and blood pressure, with responses comparable to or greater than those observed with auto-injectors and manual intramuscular epinephrine in the company’s studies. Anaphylm remains investigational and is not FDA-approved, although the FDA has conditionally approved the product’s proposed proprietary name, with final approval of the name dependent on approval of the product candidate.
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Aquestive Prepares for Potential Anaphylm Launch
The NDA resubmission moves Aquestive into another regulatory review stage as the company prepares for a potential allergist-focused launch if Anaphylm receives FDA approval. The company said its development strategy is focused on addressing practical barriers associated with carrying and administering injectable epinephrine, while continuing to advance its proprietary drug-delivery technologies. Anaphylm is the lead program within Aquestive’s AdrenaVerse™ platform, which includes more than 20 epinephrine prodrugs being explored for potential allergy and dermatological applications. The company is also developing AQST-108 epinephrine topical gel for potential dermatological indications and operates as both a proprietary product developer and a contract development and manufacturing organization. The FDA’s forthcoming classification and review timeline for the resubmitted NDA will determine the next regulatory milestone for Anaphylm and its potential path toward commercialization.
Source: Aquestive Therapeutics press release
