for severe allergic reactions (anaphylaxis) — emergency treatment
FDA issued a Complete Response Letter on January 30, 2026. Per Aquestive, the CRL requested a human factors study addressing packaging and administration, and a confirmatory pharmacokinetic study. Aquestive resubmitted the NDA on September 17, 2026.
Anaphylaxis is a severe allergic reaction in which the immune system overreacts to a normally harmless substance, causing symptoms like shortness of breath and swelling that can become life-threatening within minutes. Anaphylm is a thin film placed under the tongue that delivers epinephrine, the standard emergency hormone that reverses those reaction symptoms, without requiring water or swallowing. Because rapid epinephrine delivery is what matters most during anaphylaxis, this film format could let someone treat a severe reaction quickly and easily — though its benefits are still being reviewed.