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Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film
Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) study
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) study designsFinal FDA meeting minutes expected by early May 2026 WARREN, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (\"Aquestive\" or the \"Company\"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the receipt of preliminary comments and successful completion of an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of the Company's New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis. “The Type A Meeting with FDA confirmed our approach on several key program elements, and we are grateful to the Agency for the productive dialogue on the next steps for our Anaphylm program,” said Daniel Barber, President and Chief Executive Officer of Aquestive. “We are already hard at work preparing for our human factors and PK studies in support of our planned Anaphylm NDA resubmission in the third quarter of this year. We continue to believe Anaphylm, the first and only oral epinephrine rescue medication, has the potential to be transformative for those at risk of life-threatening allergic reactions. We want to thank the many patients, healthcare providers, and patient advocacy organizations who have expressed support for our program. Our commitment to address the long-unmet needs of this community remains strong.” Aquestive provided the proposed PK study design to the FDA prior to the Type A meeting and received preliminary comments in advance of the meeting. Most of the preliminary comments provided by the FDA were focused on ensuring consistency between past PK studies conducted by the Company and the proposed current design. The Company plans to address all feedback received by the Agency in the PK study design. In addition, the Company and FDA aligned on the concept of including labeling language to manage potential chewing of the film rather than creating additional clinical data. The FDA also provided preliminary comments on Aquestive’s HF validation study design provided by the Company to the ...