Aquestive Therapeutics announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film. The product is an investigational treatment for severe Type I allergic reactions, including anaphylaxis. The resubmission follows the company's receipt of a Complete Response Letter (CRL) from the FDA earlier this year.
Key Details
- Regulatory Action: The NDA was resubmitted on September 17, 2026, to address deficiencies identified in the FDA's Complete Response Letter dated January 30, 2026.
- Supporting Data: The filing is supported by new data from a human factors study and a confirmatory pharmacokinetic (PK) study, which evaluated revised packaging and instructions for use.
- Key Improvement: The updated packaging and instructions significantly improved usability, reducing the median pouch-opening time from 17 seconds to 3 seconds in the human factors study.
- Next Steps: The FDA will review the resubmission, determine its classification, and establish a new review timeline for potential approval.