Aquestive reports study results for Anaphylm ahead of NDA resubmission

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Go back to Aquestive reports study results for Anaphylm ahead of NDA resubmission

Aquestive Therapeutics Announces Positive Topline Human Factors and Pharmacokinetic Study Results for Anaphylm™ (dibutepinephrine) Sublingual Film

August 10, 2026 7:00 AM EDT

Human factors and clinical study results support planned resubmission of Anaphylm NDA in the third quarter of 2026Self-administration pharmacokinetic (PK) results were comparable to clinician-administered PK resultsRevised packaging design reduced median time to open pouch from 17 seconds in the previous human factors study to 3 secondsRevised instructions for use reduced incorrect film placement from previous human factors validation study by over 80%... More