Anaphylm (dibutepinephrine) - (103)

September 17, 2026: Aquestive Therapeutics (NASDAQ: AQST) resubmitted its NDA to the FDA for Anaphylm (dibutepinephrine) sublingual film for treatment of Type I allergic reactions, including anaphylaxis. The resubmission follows a January 30, 2026 Complete Response Letter on the original March 2025 NDA that requested a human factors study on packaging/administration and a confirmatory PK study.

The company said the resubmission is supported by positive topline human factors and pharmacokinetic results announced in August 2026. Revised packaging and instructions for use reduced median pouch-opening time from 17 seconds to 3 seconds. In the confirmatory PK study in healthy volunteers, which evaluated self-administration and clinician administration using revised packaging/instructions and included manual intramuscular epinephrine as a comparator, no protocol-defined use errors were observed in the self-administration arm.

The company also cited prior clinical data showing rapid onset and pharmacodynamic effects on heart rate and blood pressure comparable to or greater than auto-injectors and manual IM epinephrine. Next catalyst: FDA will determine the NDA resubmission classification and set the applicable review timeline after its initial review of the filing.