Aquestive reports positive human factors and PK data for Anaphylm ahead of NDA resubmission

Aquestive Therapeutics announced on August 10, 2026 topline results from a human factors validation study and a pharmacokinetic study for Anaphylm (dibutepinephrine) sublingual film, conducted in support of the company's planned resubmission of its New Drug Application to the FDA for treatment of Type 1 allergic reactions, including anaphylaxis.¹

The studies followed a setback: Aquestive received a Complete Response Letter from the FDA in January 2026 indicating that in a previous human factors study, participants had difficulty opening the pouch, tore the film, incorrectly placed it, chewed it, or removed it after administration.¹

The new human factors study tested revised packaging and instructions. The median time to open the pouch fell from 17 seconds to 3 seconds, the number of participants with difficulty opening the pouch dropped from 26 out of 166 to 1 out of 105, incorrect film placement fell from 20 out of 166 to 2 out of 105, and no participants were observed chewing or removing the film in the latest study.¹

In the companion pharmacokinetic study, Aquestive compared self-administration to clinician administration and manual intramuscular administration in healthy volunteers, and no administration errors occurred in the self-administration arm.¹ Geometric mean Cmax was 391.7 pg/mL for self-administered Anaphylm, 357.6 pg/mL for clinician-administered Anaphylm, and 334.5 pg/mL for manual IM administration, with median Tmax of 12 minutes for both Anaphylm arms versus 45 minutes for IM.¹

At FDA's request, the company also tested purposely misplaced administration on top of the tongue. This arm showed a geometric mean Cmax above 100 pg/mL and median Tmax of 35 minutes, with pharmacodynamic results the company described as comparable to or greater than injectable epinephrine.¹

No serious adverse events, serious events, or discontinuations occurred during the PK study.¹ Aquestive said it remains on track to complete the NDA resubmission in the third quarter of 2026.¹ The company is also advancing regulatory submissions for Anaphylm in Canada, the UK, and the European Union.¹