Aquestive Therapeutics announced positive topline results from its human factors (HF) and pharmacokinetic (PK) studies for Anaphylm™ (dibutepinephrine) sublingual film, an oral treatment for severe allergic reactions. The results address usability issues previously raised by the FDA and will support a planned resubmission of the New Drug Application (NDA) in the third quarter of 2026.
Key Details
- NDA Resubmission: The company is on track to resubmit its NDA for Anaphylm™ to the U.S. FDA in Q3 2026, following a Complete Response Letter received in January 2026.
- Human Factors Study Improvements: A revised packaging design and new instructions significantly improved usability. The median time to open the pouch was reduced from 17 seconds to 3 seconds, and incorrect film placement decreased by over 80%.
- Pharmacokinetic (PK) Results: The study showed that self-administration PK results (Geometric Mean Cmax: 391.7 pg/mL; Median Tmax: 12 minutes) were comparable to clinician-administered results, meeting key endpoints.