Aquestive Therapeutics reaffirms timeline, pathway for Anaphylm

Aquestive Therapeutics 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 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. “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.” 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 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.”