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A Pilot Crossover PK Study Comparing Different Auto-injectors and Epinephrine 0.3mg Manual Injection, Including a Repeat Dose of Anaphylm

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Trial Profile

A Pilot Crossover PK Study Comparing Different Auto-injectors and Epinephrine 0.3mg Manual Injection, Including a Repeat Dose of Anaphylm

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Oct 2024

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At a glance

  • Drugs AQST 109 (Primary) ; AQST 109 (Primary)
  • Indications Anaphylaxis
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms EPIPHAST II
  • Sponsors Aquestive Therapeutics

    • Most Recent Events

    • 27 Sep 2024 According to an Aquestive Therapeutics media release, company remains on track to hold the pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024 as it has recently submitted a meeting request letter to the FDA. Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of 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).
    • 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.

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