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.123
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.123
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.123
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 treatment.13
Allergist Jay Lieberman, MD, expressed optimism about Aquestive addressing the patient experience issues and the need for more epinephrine options.13
Sources:
1. https://www.globenewswire.com/news-release/2026/02/02/3230115/0/en/Aquestive-Therapeutics-Announces-FDA-Issuance-of-Complete-Response-Letter-for-Anaphylm.html
2. https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment
3. https://www.contemporarypediatrics.com/view/fda-issues-complete-response-letter-for-sublingual-epinephrine-film-anaphylm