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Aquestive Therapeutics Doses First Patient in Phase 3 Pivotal Clinical Study Evaluating Pharmacokinetics and Pharmacodynamics of Anaphylm™ (epinephrine) Sublingual Film
Commences initial Phase 3 study with first orally delivered epinephrine prodrug candidateReaffirms topline data anticipated in first quarter 2024 WARREN,
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Commences initial Phase 3 study with first orally delivered epinephrine prodrug candidateReaffirms topline data anticipated in first quarter 2024 WARREN, N.J., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the first patient has been dosed in its initial Phase 3 pivotal Pharmacokinetic (PK) clinical study of Anaphylm™ (epinephrine) Sublingual Film. Anaphylm is the Company’s orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. The two-part, Phase 3, single-center, open-label, randomized study is designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine IM injection and epinephrine autoinjectors (EpiPen® and Auvi-Q®) in healthy adult subjects. The primary objective is to compare the PK of epinephrine following the single administration of Anaphylm to single administration of epinephrine IM injection in healthy adult subjects. The secondary objectives include evaluating PK sustainability following repeat administration and evaluating the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors. “With the dosing of our first patient, we are officially one step closer to reaching our goal of filing our Anaphylm New Drug Application with the FDA in 2024,” said Daniel Barber, Chief Executive Officer of Aquestive. “Anaphylm continues to be 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. We remain focused on continuing to demonstrate the PK comparability of Anaphylm to existing autoinjectors. We remain excited to address the significant unmet need for an orally delivered, convenient and effective product candidate.” Part A of the two-part Phase 3 is designed as a three-period, three-treatment, six sequence, comparative PK study and is expected to enroll up to 36 subjects. Par...