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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: 14 Feb 2026

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At a glance

  • Drugs AQST 109 (Primary) ; AQST 109 (Primary)
  • Indications Anaphylaxis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics

Most Recent Events

  • 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.
  • 02 Feb 2026 According to an Aquestive Therapeutics media release, the company has received a Complete Response Letter (CRL) from the USFDA on January 30, 2026 for the NDA seeking approval of Anaphylm (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions. The Agency indicated that the HF and PK studies need to be conducted in parallel. The Company will request a Type A meeting to discuss the most efficient path for resubmission. The Company estimates resubmission in Q3 2026.
  • 04 Sep 2025 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film.

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