Aquestive resubmits Anaphylm NDA to FDA; addresses CRL with positive human factor/PK data

Aquestive Therapeutics, Inc.

Resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film to FDA on Sept 17, 2026, for Type I allergic reactions including anaphylaxis.
Human factors study with revised packaging cut median pouch-opening time from 17s to 3s; no protocol-defined use errors in self-administration arm of confirmatory PK study.
Original NDA filed March 2025; FDA CRL issued Jan 30, 2026, requested human factors and confirmatory PK studies.
FDA will determine resubmission classification and set review timeline after initial review of the resubmission.

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