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Aquestive Therapeutics Announces Positive Topline Pharmacokinetic Data for Anaphylm™ (epinephrine) Sublingual Film
Reports positive topline data from latest pilot pharmacokinetic (PK) studyPlans to submit pivotal PK clinical study protocol to the FDA in early
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Reports positive topline data from latest pilot pharmacokinetic (PK) studyPlans to submit pivotal PK clinical study protocol to the FDA in early AugustAnticipates commencement of its definitive pivotal PK clinical trial in the fourth quarter of 2023 WARREN, N.J., July 27, 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 data from its latest clinical crossover pilot trial, Study AQ109103 (the “103 study”), for Anaphylm™ (epinephrine) Sublingual Film. This crossover clinical trial in healthy human subjects was designed with the finalized dosing instructions expected for use in the Company’s upcoming pivotal clinical trial. The 103 study demonstrated that Anaphylm, using the finalized dosing administration instructions, delivers epinephrine systemically as effectively as either commercially available autoinjectors or the manual intramuscular (IM) injection. Administration of Anaphylm 12mg resulted in a geometric mean maximum epinephrine concentration (Cmax) of 457 pg/mL and a median time to maximum concentration (Tmax) of 15 minutes after administration. The partial Area Under the Curve measurement, or pAUC, was bracketed between previously generated manual 0.3mg IM injection and epinephrine 0.3mg autoinjector data at all timepoints between 10 and 60 minutes, post-dosing. Importantly, Anaphylm 12mg met the standards of bracketing in the 103 study for all the critical parameters that the Company anticipates measuring in the pivotal PK study including Cmax and pAUC during the critical early time periods, while remaining similar to autoinjectors for Tmax. The product was safe and well-tolerated with no serious adverse events. Chart 1 below highlights Anaphylm 12mg pAUC from the103 study when compared to autoinjector and manual IM injection pAUC from a previous study conducted by the Company. Chart 1: Anaphylm 12mg Exceeds Lower Bracket at All Expected Pivotal Targets1 1. Bracketing end points subject to alignment with FDA. Cross-study comparison from AQ109102 and AQ109103. The 103 study also included crossover arms of Anaphylm 12mg with alternate dosing instructions as well as Anaphylm 14mg with the ...