Aquestive Seeks Anaphylm FDA Approval Following New Packaging Tests
- 5 days ago
- 2 min read
Aquestive Therapeutics announced on February 2, 2026, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) Sublingual Film. While the FDA declined to approve the drug in its current form, the deficiencies were limited to packaging, labeling, and administration issues—specifically "human factors".
The agency noted instances where users had difficulty opening the pouch or incorrectly placed the film, which could pose safety risks during a severe allergic reaction. Crucially, the FDA did not raise concerns regarding the drug’s effectiveness, safety, or manufacturing processes.
Aquestive plans to move rapidly toward an Anaphylm FDA Resubmission by the third quarter of 2026. To satisfy regulatory requirements, the company is implementing the following measures: Modified Packaging: Redesigning the pouch opening and updating instructions for use and carton labeling. Parallel Studies: Conducting a new human factors (HF) validation study and a single pharmacokinetics (PK) study simultaneously to confirm that packaging changes do not impact drug absorption. Regulatory Meeting: Requesting a Type A meeting with the FDA to confirm the most efficient path forward.
Despite the delay, investor confidence remains high; shares of Aquestive rose over 43% following the announcement, as analysts noted that the market had already anticipated potential labeling deficiencies.
Medical experts also remain optimistic. Dr. Jay Lieberman noted that the FDA’s focus on "patient experience issues" does not diminish the drug's potential as a vital needle-free alternative to auto-injectors like the EpiPen. Anaphylm's clinical trials previously showed it could reach peak epinephrine concentrations faster than traditional injectors, with a median time of 12 minutes compared to 20 minutes for an EpiPen.
While the U.S. timeline has shifted, Aquestive is proceeding with international filings. The European Medicines Agency (EMA) indicated that no further clinical trials are needed for approval in the EU. The company expects to submit applications in both Europe and Canada in the second half of 2026.
Aquestive remains well-capitalized to complete the U.S. approval process and global launch, maintaining its commitment to providing a non-invasive, easy-to-carry treatment for the allergy community.
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Anaphylm FDA approval
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