Aquestive Therapeutics Inc. (NASDAQ:AQST) on Thursday said it has officially resubmitted its New Drug Application to the U.S. Food and Drug Administration for Anaphylm.
FDA Resubmission
The sublingual film aims to treat severe Type I allergic reactions, including life-threatening anaphylaxis.
The regulatory resubmission follows a Complete Response Letter that the FDA issued on Jan. 30, 2026.
Regulators requested that the pharmaceutical company complete a confirmatory pharmacokinetic study and a human factors study focused on packaging and drug administration.
Aquestive subsequently held a Type A meeting with the agency to determine the best approach for resolving these matters.
To address the FDA’s requests, Aquestive executed a human factors study assessing modified packaging. These revisions featured updates to the carton labeling, pouch opening, and user instructions.
Furthermore, the company finished a confirmatory pharmacokinetic trial using healthy volunteers.
The study evaluated both clinician administration and self-administration of the medication with the newly revised packaging and instructions. Researchers compared the sublingual film against manual intramuscular epinephrine.
Notably, the self-administration cohort experienced no protocol-defined use errors during the trial.
Epinephrine Delivery
Anaphylm acts as an investigational epinephrine prodrug built on a polymer matrix platform.
The medicine dissolves immediately upon contact inside the mouth, eliminating the need for swallowing or drinking water.
The film weighs under an ounce and matches the size of a standard postage stamp.
Patients can easily carry the treatment in a pocket, and the packaging resists weather extremes like rain and direct sunlight.
While the FDA has conditionally approved the Anaphylm trade name, final brand name approval remains contingent on the ultimate authorization of the product candidate.
AQST Stock Price Activity: Aquestive Therapeutics shares are trading lower by 1.04% at $4.97 during premarket trading on Thursday, according to Benzinga Pro data.
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