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The FDA provided clear guidance on its expectation that AQST-109 PK performance be reasonably bracketed between approved injectable epinephrine products with similarity to epinephrine PK via auto-injectors, since autoinjectors are the most commonly used device for self-treatment

Aquestive Therapeutics Announces Completion of FDA End-of-Phase 2 Meeting For AQST-109 ...

Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced the completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (“FDA”) for AQST-109 (epinephrine sublingual film) for the treatment of severe allergic reactions including anaphylaxis

By Aquestive Therapeutics, Inc.
Published - Dec 22, 2022, 08:06 AM ET
Last Updated - Apr 01, 2024, 03:17 PM EDT
  • FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies
  • FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance and patient administration attributes
  • Company continues to anticipate a potential product launch in 2025 with an NDA submission in first half of 2024
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