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A Pharmacokinetic Study of AQST-108

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Trial Profile

A Pharmacokinetic Study of AQST-108

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 11 Mar 2022

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At a glance

  • Drugs AQST 108 (Primary)
  • Indications Anaphylaxis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics

    • Most Recent Events

    • 08 Mar 2022 According to an Aquestive Therapeutics media release, the company anticipates conducting an end of Phase 2 meeting with the FDA and commencing the pivotal PK study in the second half of 2022.
    • 08 Mar 2022 According to an Aquestive Therapeutics media release, the company has received a written response from the FDA in December 2021 to its Pre-Investigational New Drug Application (IND) meeting submission confirming that the development of AQST-109 for the treatment of anaphylaxis under the 505(b)(2) approval pathway is acceptable and AQST-109 has the potential to meet the regulatory criteria for Fast Track designation.
    • 24 Feb 2022 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug Application (IND) for AQST-109 epinephrine oral film.

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