Aquestive Therapeutics Inc. has officially resubmitted its New Drug Application to the U.S. Food and Drug Administration for Anaphylm, an investigational sublingual film designed to treat severe Type I allergic reactions, including life-threatening anaphylaxis. According to company disclosures reported by Benzinga, this regulatory step follows a Complete Response Letter issued by the agency on January 30, 2026.
Aquestive Resubmits Anaphylm NDA to FDA
Addressing Prior Regulatory Hurdles
The FDA previously asked the pharmaceutical company to complete a confirmatory pharmacokinetic study alongside a human factors study focused on product packaging and administration.
In response, Aquestive held a Type A meeting with regulators to map out the required steps. Company statements confirm the firm subsequently completed a human factors study evaluating a modified packaging design. These updates featured revisions to carton labeling, pouch opening mechanisms, and user instructions.
Trial Data and Self-Administration Performance
Alongside packaging adjustments, Aquestive finished a confirmatory pharmacokinetic trial involving healthy volunteers.
Researchers evaluated both physician-administered dosing and patient self-administration utilizing the updated packaging and instructions. The trial directly compared the sublingual film against manual intramuscular epinephrine. Data from the evaluation showed that the self-administration cohort recorded zero protocol-defined use errors.
Polymer Matrix and Everyday Portability
Anaphylm functions as an investigational epinephrine prodrug built on a polymer matrix platform.
The medication dissolves immediately upon contact with the oral mucosa, removing the requirement for swallowing or drinking water. Weighing less than an ounce, the product matches the approximate dimensions of a standard postage stamp. Furthermore, it is packaged in a primary container that is thinner and smaller than a standard credit card.
Commercial Branding Status
Patients can easily carry the treatment in a pocket. The housing is designed to withstand environmental exposure such as rain and direct sunlight.
While the FDA previously granted tentative approval for the trade name Anaphylm, final commercial branding clearance remains contingent upon the ultimate regulatory approval of the drug candidate itself.