Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™

Core Viewpoint - Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Anaphylm™ (dibutepinephrine) Sublingual Film, which is intended for treating Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more [1][2] Group 1: FDA Response and Company Actions - The CRL highlighted deficiencies related to human factors in the Anaphylm validation study, specifically issues with pouch opening and film placement that could pose safety risks [2][3] - The company plans to modify the pouch design and labeling, and conduct a new human factors validation study to address the FDA's concerns [2][4] - No additional studies were requested by the FDA, and the company believes it can resolve the identified deficiencies quickly, aiming for resubmission in Q3 2026 [3][6] Group 2: Clinical Development and Market Strategy - The original NDA submission for Anaphylm is supported by a comprehensive clinical program involving 11 studies with approximately 967 administrations across 411 subjects, demonstrating a comparable pharmacokinetic profile to leading epinephrine auto-injectors [7][8] - The company is advancing its global expansion strategy for Anaphylm, with regulatory engagements initiated in Canada, Europe, and the UK, expecting to submit applications in the second half of 2026 [5][6] Group 3: Financial Position and Future Outlook - The company remains well-capitalized and anticipates ending 2026 with significant cash reserves, which will support the Anaphylm approval and pre-launch processes in the U.S. and other key markets [6][9] - The company is committed to bringing Anaphylm to the allergy community and believes in its potential as a non-invasive treatment option for severe allergic reactions [2][8]