for severe allergic reactions (anaphylaxis) — emergency treatment
NDA· Priority Review
FDA issued a Complete Response Letter for the Anaphylm NDA on February 2, 2026. Specific deficiency details would require sponsor 8-K review; sublingual epinephrine bioavailability and consistency in stressed-anaphylaxis conditions are the typical regulatory concerns.
About
Anaphylaxis is a severe, life-threatening allergic reaction that can cause dangerous swelling and breathing difficulties. Anaphylm is a thin film that dissolves under the tongue to deliver the standard emergency medicine, epinephrine, into the bloodstream. This needle-free method could allow for faster, easier treatment during a crisis when using an auto-injector might be difficult.
