Aquestive posts Anaphylm study presentation on investor website
AQST•PK study results and presentation details
PK study: geometric mean Cmax 391.7 pg/mL self-administered vs 357.6 clinician-administered; median Tmax 12 minutes for both.
Manual IM comparator showed geometric mean Cmax 334.5 pg/mL; median Tmax 45 minutes.
Misplaced top-of-tongue arm reported Cmax above 100 pg/mL, median Tmax 35 minutes, clinically meaningful PD comparable to injectables.
Presentation posted on the Events and Presentations page of the Investor section: https://www.aquestive.com.
Presentation outlines improved human factors and PK results for Anaphylm
Aquestive Therapeutics published a presentation outlining improved human factors and PK results for Anaphylm (dibutepinephrine) sublingual film.
Data support a planned Anaphylm NDA resubmission in Q3 2026, less than eight months after the FDA’s January 2026 CRL.
Revised packaging cut median pouch-opening time to 3 seconds from 17 seconds in the prior study.
HF errors fell sharply: difficulty opening dropped to 1 of 105 from 26 of 166; incorrect placement to 2 of 105 from 20 of 166.
