On March 30, 2026, Aquestive Therapeutics, Inc. announced the successful completion of an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, aimed at treating Type 1 allergic reactions, including anaphylaxis. The meeting provided the company with preliminary comments and feedback from the FDA, which confirmed their approach on several key program elements. Daniel Barber, President and CEO of Aquestive, expressed gratitude for the productive dialogue with the FDA, emphasizing the importance of the Anaphylm program for patients at risk of life-threatening allergic reactions. The company is now preparing for human factors and pharmacokinetic studies to support the planned NDA resubmission in the third quarter of 2026. The FDA's feedback focused on ensuring consistency between past pharmacokinetic studies and the proposed current design, and the company plans to address all feedback received. Additionally, the FDA provided comments on the human factors validation study design, recommending changes to user groups included in the study. The company believes there is general alignment with the FDA on key elements of the study. The Anaphylm product is positioned to be the first and only oral epinephrine rescue medication, which could significantly improve treatment options for those at risk of severe allergic reactions. The company is also advancing regulatory submissions for Anaphylm in Canada and the European Union, reinforcing its commitment to addressing the unmet needs of this community.

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