Aquestive Therapeutics Unveils Clinical Data for Anaphylm at AAAAI 2026
Event summary
- Aquestive Therapeutics will present new clinical data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting, February 27-March 2.
- Data shows Anaphylm achieves clinically relevant epinephrine plasma concentrations without diastolic blood pressure dip.
- Anaphylm is designed as an easy-to-carry alternative to injectable epinephrine for severe allergic reactions.
- If approved, Anaphylm would be the first and only oral medication for anaphylaxis rescue treatment.
The big picture
Aquestive Therapeutics is advancing Anaphylm as a potential game-changer in anaphylaxis management, addressing long-standing barriers to epinephrine use. The clinical data presented at AAAAI 2026 highlights its differentiated profile, which could reshape the $2B+ global epinephrine auto-injector market if regulatory hurdles are cleared. The company's focus on innovative delivery technologies positions it at the forefront of allergy treatment advancements.
What we're watching
- Regulatory Pathway
- Whether the FDA will approve Anaphylm given the Complete Response Letter issued in January 2026.
- Market Adoption
- The pace at which Anaphylm could gain acceptance as an alternative to injectable epinephrine if approved.
- Competitive Dynamics
- How Aquestive positions Anaphylm against existing anaphylaxis treatments and potential future competitors.
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