Aquestive Therapeutics Clears Key Hurdles for Anaphylm NDA Resubmission — Aquestive Therapeutics, Inc.

Event summary

Aquestive Therapeutics reported positive topline results from human factors and pharmacokinetic studies for Anaphylm™ (dibutepinephrine) sublingual film.
Revised packaging design reduced median time to open pouch from 17 seconds to 3 seconds, addressing FDA concerns.
Self-administration pharmacokinetic results were comparable to clinician-administered results, with no administration errors observed.
Top-of-tongue placement showed clinically meaningful pharmacodynamic results, even if used incorrectly.
Company plans to resubmit Anaphylm NDA in the third quarter of 2026.

The big picture

Aquestive Therapeutics' positive study results mark a critical step toward resubmitting its NDA for Anaphylm, a potential first-of-its-kind non-invasive epinephrine treatment. The company's ability to address FDA concerns through packaging and instruction revisions highlights its focus on improving patient accessibility during emergencies. Success in this space could position Aquestive as a key player in the allergy treatment market, competing with established injectable epinephrine products.

What we're watching

Regulatory Timelines: Whether the FDA will accept the revised data and packaging design in the upcoming NDA resubmission.
Market Differentiation: How Anaphylm's non-invasive, orally delivered epinephrine product will compete with existing injectable options if approved.
Execution Risk: The pace at which Aquestive can advance regulatory submissions for Anaphylm in Canada, the UK, and the European Union.