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A pivotal Phase 3, single-center, open-label, randomized study to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm (AQST-109 ) versus single and repeat doses of the epinephrine intra-muscular (IM) injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects

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Trial Profile

A pivotal Phase 3, single-center, open-label, randomized study to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm (AQST-109 ) versus single and repeat doses of the epinephrine intra-muscular (IM) injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2026

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At a glance

Most Recent Events

  • 30 Mar 2026 According to an Aquestive Therapeutics media release, the company announced the receipt of preliminary comments and successful completion of an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of the Company's New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis with Final FDA meeting minutes expected by early May 2026.
  • 20 Feb 2026 According to an Aquestive Therapeutics media release, data from this study will be featured at the 2026 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. The meeting will take place February 27-March 2, 2026, in Philadelphia, PA.
  • 02 Feb 2026 According to an Aquestive Therapeutics media release, Company received positive feedback from the European Medicines Agency (EMA) that no further clinical trials are needed prior to regulatory approval submission. Aquestive expects to submit its marketing authorization application in Europe as well as its New Drug Submission (NDS) in Canada in 2H 2026. MHRA feedback also expected in Q1 2026.

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