Aquestive resubmits Anaphylm FDA application
- Aquestive Therapeutics (NASDAQ:AQST) resubmitted its FDA application for Anaphylm, a sublingual film treatment for Type I allergic reactions.
- The resubmission follows additional human factors and pharmacokinetic studies requested after an FDA Complete Response Letter.
- Aquestive said revised packaging reduced median pouch-opening time from 17 seconds to 3 seconds.
Aquestive Therapeutics (NASDAQ:AQST) resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for Anaphylm (dibutepinephrine) sublingual film, a treatment candidate for Type I allergic reactions including anaphylaxis.
The resubmission follows the FDA’s January 30, 2026 Complete Response Letter and includes additional human factors and pharmacokinetic studies completed by the company.
The company said revised packaging and instructions for use reduced median pouch-opening time from 17 seconds to 3 seconds, while a confirmatory pharmacokinetic study reported no protocol-defined use errors in the self-administration group.
Aquestive Therapeutics develops pharmaceutical products using drug delivery technologies, including its sublingual film platform for treatments requiring alternative administration methods.
The FDA will determine the classification of the resubmitted application and provide a review timeline after completing its initial assessment, while Aquestive cited clinical data showing rapid onset and cardiovascular responses comparable with auto-injectors and manual intramuscular epinephrine.
