Aquestive Therapeutics plans to present clinical trial data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia. The presentation will highlight findings demonstrating that the investigational treatment achieved clinically meaningful epinephrine plasma concentrations while maintaining stable diastolic blood pressure levels, addressing a key safety concern in anaphylaxis management.
The sublingual film formulation represents a novel approach to emergency allergy treatment, potentially offering an alternative to injectable epinephrine auto-injectors. Current anaphylaxis protocols rely primarily on intramuscular epinephrine administration, which requires patient training and immediate access to devices. An oral alternative could expand treatment options across various patient populations and care settings.
If approved by the U.S. Food and Drug Administration, Anaphylm would become the first oral medication indicated for severe allergic reactions. The company's decision to present clinical data at a major medical conference suggests advancement toward regulatory review, though development timelines and approval pathways remain subject to FDA evaluation.