Aquestive Therapeutics announced on January 9, 2026, that the FDA identified unspecified deficiencies in the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) Sublingual Film — a needle-free, sublingual epinephrine film for severe allergic reactions.
Aquestive is actively working with the FDA to understand and resolve the issues quickly.
Anaphylm, if approved, would be the first oral/sublingual epinephrine product — a thin, water-free film that dissolves under the tongue, more portable than auto-injectors. The NDA is supported by 11 studies (967 administrations in 411 subjects), showing PK comparable to leading auto-injectors and a similar safety profile.
CEO Dan Barber said: “We remain confident about Anaphylm and its potential to be the first and only FDA-approved sublingual film for this indication".
Clinical data supported rapid symptom resolution (e.g., starting within 2 minutes in oral allergy challenge studies).
Food allergy - Only 3 ways to treat allergies (click to enlarge the image).
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