USFDAAug 10, 2026, 07:12 AM
Aquestive Anaphylm™ Study Results Support FDA Resubmission
AI Summary
Aquestive Therapeutics announced positive topline results from its human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film. These results support the planned resubmission of its New Drug Application (NDA) to the U.S. FDA in the third quarter of 2026 for the treatment of Type 1 allergic reactions. The revised packaging and instructions significantly improved ease of use, and both self-administered and even purposely misplaced film showed clinically meaningful results.
Key Highlights
- Human factors and clinical study results support planned Anaphylm™ NDA resubmission in Q3 2026.
- Median time to open pouch reduced from 17 seconds to 3 seconds in human factors study.
- Incorrect film placement reduced from 20 to 2 participants (over 80% reduction).
- Self-administration PK results for Anaphylm™ were comparable to clinician-administered results.
- Top-of-tongue placement showed clinically meaningful pharmacodynamic results.
- Self-administered Anaphylm™ Cmax was 391.7 pg/mL with a median Tmax of 12 minutes.
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