Aquestive Resubmits NDA for Anaphylm Sublingual Film to FDA

Aquestive Therapeutics has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film, a potential treatment for Type I allergic reactions, including anaphylaxis. The resubmission is supported by positive results from a topline human factors and pharmacokinetic (PK) study announced in August 2026.

According to Daniel Barber, President and CEO of Aquestive Therapeutics, the resubmission addresses the issues identified by the FDA in its Complete Response Letter (CRL) issued in January 2026.

The completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use. Specifically, the median pouch-opening time was reduced from 17 seconds to 3 seconds, making the treatment more accessible and user-friendly. The Company also completed a confirmatory PK study in healthy volunteers, evaluating self-administration and clinician administration of Anaphylm, with manual intramuscular epinephrine as a comparator. No protocol-defined use errors were observed in the self-administration arm of the PK study.

Anaphylm™ (dibutepinephrine) sublingual film is a polymer matrix-based epinephrine prodrug. It is designed to be a small, highly portable, and needle-free treatment option for severe allergic reactions. The product is about the size of a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging is thinner and smaller than an average credit card, making it easy to carry in a pocket. It is also designed to withstand weather excursions such as exposure to rain and sunlight.

The Company's original NDA for Anaphylm was submitted in March 2025. Following the receipt of the CRL, Aquestive held a Type A meeting with the FDA to discuss the Company’s proposed approach to addressing the matters identified in the CRL. The CRL requested that the Company complete a human factors study addressing packaging and administration, and a confirmatory PK study of Anaphylm.

The Company’s conviction in Anaphylm's potential has never been stronger. If approved, the product could represent a meaningful advancement in the treatment of severe allergic reactions, including anaphylaxis. Golden, M.D.C.M., lead author of the 2023 Anaphylaxis Practice Parameter and a member of Aquestive's Scientific Advisory Board.

The FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission. The Company is moving with urgency to bring Anaphylm to the patients who need it most, as it prepares for a focused, allergist-first launch.