Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm™.
As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023. The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA. In addition, the Company’s current development plan continues to include a standard repeat-dose study of Anaphylm and an already-approved comparator.
Earlier this year, the Company disclosed repeat-dose data of Anaphylm 12mg at 25 minutes post initial dosing from Study AQ109102 including a cross-study comparison to epinephrine manual injection 0.3mg with a repeat dose at 10 minutes post initial dosing. Further information on this comparison is available in the Company’s corporate presentation located on the Investor page of the Company’s website.
https://finance.yahoo.com/news/aquestive-therapeutics-reaffirms-timeline-pathway-130400102.html
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