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# Aquestive’s Epinephrine Film Gets Complete Response
- URL: https://www.fdaweb.com/aquestives-epinephrine-film-gets-complete-response/
- Published: 2026-02-02T12:00:00.000Z
- Updated: 2026-09-14T15:32:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160582

FDA has issued Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic reactions, including anaphylaxis. FDA identified concerns in the product’s human factors validation study, including difficulty opening the pouch and incorrect placement of the sublingual film, which the agency said could pose safety risks during an anaphylactic emergency, according to the company. It also cited deficiencies involving packaging and administration. FDA did not raise chemistry, manufacturing, and controls issues and did not question the comparability data included in the application, it says.

Anaphylm (dibutepinephrine) is being developed as a non-invasive alternative to epinephrine auto-injectors for patients weighing at least 30 kilograms. If approved, Anaphylm would be the first orally delivered, non-invasive epinephrine therapy for treating severe, life-threatening allergic reactions, including anaphylaxis.

To address the deficiencies, Aquestive says it has modified the pouch opening mechanism, instructions for use, and pouch and carton labeling. The company plans to conduct a new human factors validation study incorporating those changes and to address potential tolerability issues as part of its resubmission.

FDA’s letter also requested a single pharmacokinetics study to assess the impact of the packaging and labeling modifications. According to the company, the agency indicated that the human factors and pharmacokinetics studies may be conducted in parallel and did not request any additional clinical or nonclinical studies.

Based on its initial assessment of the rejection letter, Aquestive says it expects to resubmit the NDA in the third quarter of this year, and plans to request an expedited review. The company also intends to seek a Type A meeting with the FDA to discuss the most efficient path to resubmission.