Aquestive Therapeutics, Inc. announced on September 17, 2026, that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm (dibutepinephrine) sublingual film. The resubmission is intended for the treatment of Type I allergic reactions, including anaphylaxis.
The resubmission follows a Complete Response Letter (CRL) issued by the FDA on January 30, 2026. The agency had requested that the company complete a human factors study addressing packaging and administration, as well as a confirmatory pharmacokinetic (PK) study of Anaphylm.
In response, Aquestive completed a human factors study evaluating revised packaging. This study incorporated modifications to the pouch opening, instructions for use, and labeling. The company also conducted a confirmatory PK study in healthy volunteers using the revised packaging and instructions. The study evaluated both self-administration and clinician administration of Anaphylm, comparing it to manual intramuscular epinephrine. The company reported that no protocol-defined use errors were observed in the self-administration arm of the PK study.
According to the company, the revised packaging design reduced the median pouch-opening time from 17 seconds to 3 seconds. Aquestive stated that the completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging and instructions for use.
The company noted that the FDA will determine the classification of the resubmission and establish the applicable review timeline following its initial review. Aquestive’s original NDA for Anaphylm was submitted in March 2025.
