Anaphylm (dibutepinephrine) - (103)

October 15, 2026: Aquestive Therapeutics (NASDAQ: AQST) said the FDA accepted as complete its resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and classified it as a Class 2 response. The FDA set a PDUFA goal date of March 16, 2027.

The resubmission was filed September 16, 2026 after positive topline human factors and pharmacokinetic study results announced in August 2026, intended to address issues raised in the FDA’s January 30, 2026 Complete Response Letter.

Anaphylm is described as a sublingual epinephrine prodrug film; if approved, it would be the first oral rescue medication for severe allergic reactions, including anaphylaxis. The Anaphylm trade name for AQST-109 has been conditionally approved, pending product approval.

Ex-U.S., the company said its regulatory strategy remains on track, with a New Drug Submission to Health Canada planned for Q4 2026.