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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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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: 20 Aug 2024

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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

    • 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).
    • 14 Aug 2024 According to an Aquestive Therapeutics media release, company is reiterating its guidance of initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026. This is based on completing an NDA submission with the FDA in the first quarter of 2025.
    • 25 Jun 2024 Top-line data presented in an Aquestive Therapeutics Media Release.

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