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Aquestive Therapeutics Announces Completion of FDA End-of-Phase 2 Meeting For AQST-109 (epinephrine sublingual film)
FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studiesFDA provides clear guidance on approvability
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studiesFDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance and patient administration attributesCompany continues to anticipate a potential product launch in 2025 with an NDA submission in first half of 2024 WARREN, N.J., Dec. 22, 2022 (GLOBE NEWSWIRE) -- 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. The final EOP2 FDA meeting minutes provided clarity to the Company as to the FDA’s expectations regarding key program areas related to pharmacokinetics, administration and use that should be addressed given the life-threatening condition that may be treated with AQST-109, if approved. 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. From a reference listed product perspective, the FDA urged the Company to utilize multiple approved injectable products to create a bracketing of high and low epinephrine plasma concentrations as well as mean maximum concentration (Cmax) and partial area under the curve (AUC) within 30 minutes to 60 minutes after dosing (as determined by the Company) with an emphasis on the early timepoints. Based on existing data, Aquestive believes it can achieve this ‘bracketing’ standard in an adequately powered, well-controlled pivotal PK study. The FDA also provided comments on potential issues the Company will need to address in regard to a sublingually delivered product including (1) the impact of any product hold time, (2) the potential for emesis (vomiting), and (3) the impact of potential mouth conditions such as angioedema (swelling). At this time, the Company believes it can provide sufficient data related to administration ...