Aquestive Therapeutics releases Anaphylm human factors, clinical study presentation materials
Reuters2026/08/10 11:17- Aquestive Therapeutics published supplemental materials on human factors and clinical results for its Anaphylm (dibutepinephrine) sublingual film program.
- Resubmission human factors study in 105 untrained participants showed fewer use issues versus the original NDA study, including median open time cut to 3 seconds.
- PK study in healthy subjects showed self-administration comparable to clinician administration, with geometric mean Cmax 391.7 pg/mL vs 357.6 pg/mL.
- Purposeful top-of-tongue misplacement produced lower exposure, with geometric mean Cmax 112.7 pg/mL, while showing a clinically meaningful pharmacodynamic response.
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