- Aquestive Therapeutics Inc (NASDAQ:AQST) announced topline results from the first three arms of Part 3 of the EPIPHAST study for its AQST-109 epinephrine oral film for allergic reactions, including anaphylaxis.
- In the first three arms of Part 3, AQST-109 12 mg continued to show rapid absorption with favorable pharmacokinetics.
- The median time to maximum concentration was 12 minutes for AQST-109 compared to 50 minutes for the epinephrine 0.3mg intramuscular (IM) injection, the fastest median time in studies to date.
- Related: Aquestive's AQST-109 Receives Fast Track Tag For Allergic Reactions.
- The Area Under the Curve within the clinically relevant periods of 10 minutes, 20 minutes, and 30 minutes in each of the three arms were comparable for 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 0.3mg IM injection, as reported in Part 2.
- Aquestive plans to conduct a comparative study of AQST-109 and 0.3 mg EpiPen during Q3 2022. The company plans to request an FDA End-of-Phase 2 meeting in Q4 of 2022.
- Price Action: AQST shares are up 0.53% at $0.88 during the premarket session on the last check Thursday.
