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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: 06 Jul 2025

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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

  • 16 Jun 2025 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026.
  • 12 May 2025 According to an Aquestive Therapeutics media release, company anticipates receipt of notice from the FDA of the Agency's determination of acceptance of the NDA for review in the second quarter of 2025. The Company continues to maintain a constructive dialogue with the FDA, and recent changes at the U.S. Department of Health and Human Services (HHS) have not impacted the regulatory timeline for the review of the NDA submission for Anaphylm.
  • 14 Aug 2024 According to an Aquestive Therapeutics media release, company commented on the approval of a non-injection-based device for delivery of epinephrine for the treatment of severe allergic reactions, including anaphylaxis, by the United States Food and Drug Administration (FDA).

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