FDA Cites Packaging & Use Concerns in Anaphylm Rejection

The delay highlights the demand for alternative epinephrine delivery methods and the importance of user-centered design in medical device approval.

Published on Feb. 6, 2026

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The FDA's recent complete response letter regarding Aquestive Therapeutics' Anaphylm sublingual film highlights the evolving landscape of anaphylaxis treatment. While the delay is disappointing, the core message is clear: the demand for alternative epinephrine delivery methods is strong, and innovation in this space is actively sought after. The FDA's concerns were not about the drug's efficacy or safety, but rather about ease of use - a critical factor in emergency situations.

Why it matters

The Anaphylm case underscores the growing importance of human factors engineering in medical device approval. The FDA's DMEPA division is increasingly focused on identifying potential usability issues that could lead to medication errors, requiring manufacturers to prioritize user-centered design and conduct rigorous human factors testing throughout the development process.

The details

For decades, the epinephrine autoinjector has been the standard of care for anaphylaxis. However, several challenges limit its effectiveness, including fear of needles, difficulty in proper administration, and concerns about carrying the device consistently. Sublingual films, like Anaphylm, offer a needle-free alternative with the potential to overcome many of the limitations of autoinjectors. The FDA's focus on packaging and administration suggests this approach is viable, but requires refinement to ensure consistent and correct usage.

  • Aquestive Therapeutics expects to resubmit its application to the FDA by the third quarter of 2026.

The players

Aquestive Therapeutics

A pharmaceutical company developing Anaphylm, a sublingual epinephrine film for the treatment of anaphylaxis.

Elizabeth Kudlaty, MD, MS

A professor at the University of Illinois at Chicago who specializes in allergy and asthma management.

FDA

The U.S. Food and Drug Administration, the regulatory agency responsible for approving medical devices and pharmaceuticals.

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What they’re saying

“Even with readily available autoinjectors, patient education remains paramount. Clear, concise instructions and hands-on training can significantly improve administration rates during a real-life anaphylactic event.”

— Elizabeth Kudlaty, MD, MS, Professor, University of Illinois at Chicago (newsy-today.com)

What’s next

Aquestive Therapeutics expects to resubmit its application for Anaphylm to the FDA by the third quarter of 2026.

The takeaway

The Anaphylm case highlights the growing importance of user-centered design and human factors engineering in the approval of medical devices. As the demand for alternative epinephrine delivery methods continues to rise, manufacturers must prioritize ease of use and consistent administration to ensure these life-saving treatments are accessible and effective for patients.