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Pediatric PK Study of AQST-109

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Trial Profile

Pediatric PK Study of AQST-109

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Dec 2024

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At a glance

  • Drugs AQST 109 (Primary)
  • Indications Anaphylaxis
  • Focus Therapeutic Use

Most Recent Events

  • 02 Dec 2024 According to an Aquestive Therapeutics media release, The FDA also provided further guidance on additional data views to be included in the planned NDA submission and continued to emphasize their focus on pharmacokinetic sustainability for a single dose. In addition, the FDA requested minor modifications to the Company's pediatric trial protocol.
  • 02 Dec 2024 According to an Aquestive Therapeutics media release, the company announced receipt of positive feedback from U.S. FDA prior to its planned NDA submission for Anaphylm- confirms no additional adult clinical trials are necessary prior to NDA submission. FDA agreed with the Company's planned NDA content and format for the submission, planned safety evaluation, and planned pediatric trial, which has commenced at both U.S. and Canadian sites.
  • 02 Dec 2024 According to an Aquestive Therapeutics media release, the company has commenced pediatric trial in December 2024, and have a clear path to an NDA submission in the first quarter of 2025.

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