Aquestive Therapeutics releases Anaphylm human factors, clinical study presentation materials
AQST•Human factors study showed fewer use issues
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.
Top-of-tongue misplacement lowered exposure
Purposeful top-of-tongue misplacement produced lower exposure, with geometric mean Cmax 112.7 pg/mL, while showing a clinically meaningful pharmacodynamic response.
Supplemental materials released for Anaphylm program
Aquestive Therapeutics published supplemental materials on human factors and clinical results for its Anaphylm (dibutepinephrine) sublingual film program.
PK study showed comparable self-administration exposure
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.
