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Aquestive Therapeutics Reports Positive Results from Latest Clinical Studies Evaluating Pharmacokinetic and Pharmacodynamic Performance of Anaphylm ™ (epinephrine) Sublingual Film and Provides Findings from Recent Auto-Injector Clinical Study
Time to maximum blood concentration (median Tmax) for Anaphylm was 10 minutes with a range of 5 to 20 minutesEarly drug exposure at 10 minutes (partial area
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Time to maximum blood concentration (median Tmax) for Anaphylm was 10 minutes with a range of 5 to 20 minutesEarly drug exposure at 10 minutes (partial area under the curve, or pAUC0-10min) for Anaphylm was similar to Auvi-Q® (epinephrine injection) auto-injector 0.3mg and over 4 times higher than epinephrine 0.3mg manual injection, while lower than both EpiPen® (epinephrine) auto-injector 0.3mg and the generic equivalent productPharmacodynamic effects were observed as early as 2 minutes for both Anaphylm and the auto-injectorsTarget range for comparing Anaphylm to approved epinephrine formulations was successfully identified for upcoming pivotal studyCompany continues to expect to submit the protocol for the pivotal study to the FDA in third quarter 2023 WARREN, N.J., May 31, 2023 (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 released topline clinical data from recent pilot studies that were completed following the End-of-Phase 2 meeting with the FDA. The studies included examining (1) differences in pharmacokinetic (PK) results based on changes to administration instructions, (2) additional repeat dose data on Anaphylm, and (3) the differences between approved auto-injectors. “These data continue to show rapid absorption of epinephrine during the critical first ten minutes following administration of Anaphylm. As our scientific advisors and the FDA have previously stated, anaphylaxis is a serious condition that must be treated quickly. Simply put, every minute matters during a severe allergic reaction,” said Daniel Barber, Chief Executive Officer of Aquestive. “We are pleased to share the latest clinical results from our recent pilot studies confirming the rapidity of epinephrine delivery as we continue the progression of our Anaphylm development program. We expect to submit the protocol for our pivotal PK trial to the FDA during the third quarter 2023 for the Agency’s review and comments.” David Golden, M.D., allergist-immunologist and Associate Professor of Medicine at Johns Hopkins University, stated, “The latest clinical data for Anaphylm demonstrate that the sublingual film continues to deliver the pharmac...