The FDA issued a Complete Response Letter (CRL) on January 30, 2026, for Aquestive Therapeutics' New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, intended for treating Type I allergic reactions including anaphylaxis in patients weighing 30kg or more. 1 2 3 Deficiencies in the CRL are limited to human factors validation study issues, such as difficulty opening the pouch and incorrect film placement, along with labeling concerns and a required supportive PK study; no concerns raised on efficacy, safety, CMC, or comparability data. 1 2 3 Aquestive has modified the pouch opening, instructions, and labeling, and plans to conduct a new human factors validation study and PK study in parallel, targeting NDA resubmission as early as Q3 2026 with a request for rapid review. 1 2 3 CEO Daniel Barber stated the company is encouraged by the limited scope of issues and remains confident in Anaphylm's effectiveness as an easy-to-use, fast-acting epinephrine tr...
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