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# Aquestive Will Resubmit Anophylm NDA in 3rd Quarter
- URL: https://www.fdaweb.com/aquestive-will-resubmit-anophylm-nda-in-3rd-quarter/
- Published: 2026-08-11T12:00:00.000Z
- Updated: 2026-09-14T13:44:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161606

Aquestive Therapeutics says topline results from new human factors and pharmacokinetic studies of its Anophylm (dibutebinephrine) support its plan to resubmit an NDA for the drug to FDA in the third quarter of this year. A company [statement](https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-positive-topline-human-factors?ref=fdaweb.com) says the tests were conducted in response to an FDA January complete response letter that raised concerns from an earlier human factors study in which some participants had difficulty opening the pouch, tore the film during pouch opening, improperly placed the film during administration, chewed the film, and/or removed the film after administration.

Aquestive is seeking an indication for treating type 1 allergic reactions, including anaphylaxis.

Anophylm is described as sublingual film in a polymer matrix-based epinephrine investigational drug product.