Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Core Viewpoint - Aquestive Therapeutics has successfully completed a Type A meeting with the FDA regarding the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, aimed at treating Type 1 allergic reactions, including anaphylaxis [1][2] Group 1: FDA Interaction and Study Design - The Type A meeting confirmed the company's approach on key program elements and received clarifying feedback on pharmacokinetic (PK) and human factors (HF) study designs [2][7] - The FDA provided preliminary comments on the PK study design, focusing on consistency with past studies, and the company plans to address this feedback [2][3] - The FDA recommended changes to user groups in the HF study design, and the company believes there is alignment on key elements following discussions during the meeting [3] Group 2: Product Details and Market Potential - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is designed for easy administration without the need for water or swallowing, making it a unique oral epinephrine rescue medication [5] - The product is expected to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for severe allergic reactions, which could transform treatment options for patients at risk [4][8] Group 3: Future Plans and Regulatory Submissions - The company reaffirms its guidance to resubmit the Anaphylm NDA in the third quarter of 2026 and is also advancing regulatory submissions in Canada and the European Union [4][7] - The company is preparing for human factors and pharmacokinetic studies to support the planned NDA resubmission [2][4]