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Self-administration PK Study of AQST-109

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Trial Profile

Self-administration PK Study of AQST-109

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Aug 2024

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At a glance

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

Most Recent Events

  • 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.
  • 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).
  • 25 Jul 2024 According to an Aquestive Therapeutics media release, the company expects filing an NDA late in the fourth quarter of 2024 or early in the first quarter of 2025. The type C meeting with FDA has been completed and anticipate requesting a pre-New Drug Application (NDA) meeting before the end of the third quarter.

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