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Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film
WARREN, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients'
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"WARREN, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- 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. “Based on our previous interactions with the FDA and our review of publicly available disclosures, we continue to anticipate starting our pivotal trial in the fourth quarter 2023,” stated Daniel Barber, Chief Executive Officer of Aquestive. “We are focused on completing the necessary work to reach our goal of filing our NDA in 2024.” Mr. Barber continued, “We are advancing the development of Anaphylm, the first and only non-invasive, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of severe allergic reactions, including anaphylaxis. Our orally delivered product candidate comes in a highly portable package with the durability to withstand many of the norms of daily life and potentially combines the convenience with enhanced portability with positive clinical outcomes.” Aquestive has evaluated Anaphlym in six clinical studies across 200 healthy volunteers. In the most recent pilot PK study (AQ109103 or the “103” study) completed in July 2023, Anaphylm, using the proposed final dosing administration instructions, was shown to deliv...