Aquestive plans PK, human factors studies ahead of Anaphylm NDA resubmission in Q3 2026

Reuters03-30 19:05

Aquestive plans PK, human factors studies ahead of Anaphylm NDA resubmission in Q3 2026

Aquestive completed in-person FDA Type A meeting on Anaphylm (dibutepinephrine) sublingual film, clearing path to start pharmacokinetic study plus human factors validation study.
NDA resubmission timing reaffirmed for Q3 2026.
FDA feedback centered on aligning proposed PK design with prior studies; labeling language expected to address potential chewing rather than generating new clinical data.
Human factors study design revised to reflect FDA-recommended user groups; protocol slated for FDA review.
No study results were presented; PK and human factors study results will be generated ahead of planned NDA resubmission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603300700PRIMZONEFULLFEED9680319) on March 30, 2026, and is solely responsible for the information contained therein.

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