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Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains well-capitalized and anticipates ending 2026 with significant cashReiterates plans to submit in Canada and EU by the end of 2026Company to host investor call on February 2, 2026, at 8:00am ET WARREN, N.J., Feb. 02, 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 that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds). “While it is unfortunate to have received a CRL, we believe that, with the clarity we now have from the FDA, we have made significant progress toward approval. We are encouraged that the issues in the letter are limited to human factors and a supportive PK study, once human factors are addressed, and we noted several labeling comments that will inform the final label for Anaphylm, if approved by the FDA,” said Daniel Barber, President and CEO of Aquestive. “We remain confident in the effectiveness and safety of Anaphylm and its potential as an easy-to-use, easy-to-carry, fast-acting epinephrine treatment. We look forward to working with the FDA to achieve approval for Anaphylm. Our commitment to bringing this innovative therapy to the allergy community remains steadfast.” In the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors (HF) validation study. These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis. To resolve the FDA’s concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling, and plans to rapidly conduct a new HF validation study with these modifications. The Company also plans to further address poten...