ANAPHYLM™
(dibutepinephrine)
sublingual film

Current Status: PDUFA Date: 1/31/2026

Anaphylm™ (dibutepinephrine) sublingual film is the first orally delivered film formulation of epinephrine in clinical development for the emergency treatment of severe allergic reactions, including anaphylaxis.

Developed using both of Aquestive's core technologies (PharmFilm® and AdrenaVerse™), Anaphylm is designed to deliver rapid, effective treatment without the need for injection. Compact, portable, and easy to administer, Anaphylm dissolves on contact and requires no water or swallowing—ideal for real-world emergencies.

About anaphylaxis

Anaphylaxis is a life-threatening allergic reaction that can occur within minutes of exposure to triggers such as foods, medications, or insect stings. It can cause symptoms ranging from rash and swelling to airway obstruction, loss of consciousness, or even death. The standard-of-care treatment—epinephrine injection—works to reverse these effects, but timely administration is critical for survival.

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