Aquestive Therapeutics Reveals Favorable Data From Epinephrine Trial For Allergies

Aquestive Therapeutics Inc 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.