Anaphylm (dibutepinephrine) - (103)

August 11, 2026: Aquestive Therapeutics (NASDAQ: AQST) said Anaphylm (dibutepinephrine) sublingual film for type I allergic reactions including anaphylaxis completed the human factors validation study and PK study required to address the FDA’s January 30, 2026 Complete Response Letter. The revised-packaging human factors study showed significant improvement across each CRL deficiency, and preliminary PK data met the primary endpoints; no self-administration errors, serious adverse events, or discontinuations were reported. The company remains on track to resubmit the Anaphylm NDA in Q3 2026 and plans to request expedited review. It also said the CRL did not cite CMC deficiencies and did not question clinical comparability to autoinjectors. Ex-U.S. filings are planned for Canada by end-2026, the EU in Q1 2027, and additional markets including the UK in 2027.

AQST-108 (epinephrine) topical gel: the Phase 1 study in androgenic alopecia was completed with no safety concerns, and the program is being expanded into dermatologic inflammatory indications including atopic dermatitis.

Libervant (diazepam) buccal film: the product remains tentatively approved in the U.S. for patients 12+ and is expected to become eligible for full approval after another product’s orphan exclusivity expires in January 2027; Aquestive also filed for FDA approval in patients ages 6-11 in Q2 2026.