Business
Aquestive Therapeutics Reports Positive Initial Topline Data from Part 3 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film
AQST-109 is the first and only orally delivered epinephrine product candidate in clinical developmentFastest median time to maximum concentration (Tmax) in
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"AQST-109 is the first and only orally delivered epinephrine product candidate in clinical developmentFastest median time to maximum concentration (Tmax) in studies to date at 12 minutes Study continues to show AQST-109 is safe and well toleratedHead-to-head comparison study to EpiPen® scheduled to commence in third quarter 2022On track to request End-of-Phase 2 meeting with FDA in fourth quarter 2022 and thereafter to commence pivotal PK studyRemaining data from Part 3 expected to be reported in early third quarter 2022 WARREN, N.J., June 15, 2022 (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 announced positive topline results from the first three arms of Part 3 of the EPIPHAST study for its AQST-109 epinephrine oral film. The purpose of Part 3 was to continue to study the administration of the film under a variety of conditions and further characterize its pharmacokinetics, pharmacodynamics, and safety. The first three arms were designed to assess the impact of holding the film under the tongue and limiting swallowing for different periods of time. These time periods were (1) the target holding time of 4 minutes, (2) a 50% reduction in hold time to 2 minutes and (3) no hold time, or 0 minutes. The remaining two arms of the study for which data are not yet available include (4) dosing the film 2 minutes after eating a peanut butter sandwich and (5) swallowing the film immediately with 240 mL of water. In the first three arms of Part 3, AQST-109 12 mg continued to show rapid absorption with favorable pharmacokinetics across a variety of key metrics at the target hold time as follows: The median time to maximum concentration (Tmax) was observed to be 12 minutes for AQST-109 compared to 50 minutes for the epinephrine 0.3mg intra-muscular (IM) injection from Part 2 of the EPIPHAST study.The Area Under the Curve (AUC) within the clinically relevant periods of 10 minutes, 20 minutes, and 30 minutes in each of three arms were comparable for both AQST-109 and the 0.3mg IM injection.The median time to reach 100 pg/mL, which has been suggested to be the threshold for the onset of hemodynamic effects, was 8 minutes for AQST-109 and 10 minutes for the 0.3...