Aquestive Therapeutics announced positive topline results from human factors and pharmacokinetic studies for Anaphylm™ (dibutepinephrine) sublingual film, supporting its planned resubmission of a New Drug Application to the FDA in the third quarter of 2026. The revised packaging reduced median time to open the pouch from 17 seconds to 3 seconds and decreased incorrect film placement by over 80% compared to previous studies. Pharmacokinetic data showed self-administration results comparable to clinician-administered doses, with a geometric mean Cmax of 391.7 pg/mL versus 357.6 pg/mL. The company plans to address deficiencies identified in a January 2026 Complete Response Letter regarding user interface and administration errors. Aquestive Therapeutics is a pharmaceutical company specializing in oral film delivery technologies for prescription drugs.
