- Aquestive Therapeutics Inc AQST announced positive topline results from the EPIPHAST 2 trial for its AQST-109 epinephrine sublingual film.
- The trial was designed to compare single doses of AQST-109 to EpiPen 0.3mg and epinephrine 0.3mg intramuscular (IM) injection and repeat doses of AQST-109 to repeat doses of epinephrine 0.3mg IM injection.
- EpiPen auto-injectors are used for allergic emergencies.
- Related: Aquestive Therapeutics Reveals Favorable Data From Epinephrine Trial For Allergies.
- Single dose administration showed AQST-109 achieved a significantly faster Tmax (12 minutes) compared to both EpiPen (22.5 minutes) and epinephrine 0.3mg IM injection (45 minutes).
- AQST-109 repeat dosing provided significantly higher drug plasma concentrations, with a Tmax of 8 minutes after administration, and extensive absorption was observed.
- After one dose of AQST-109, maximum mean effects on systolic blood pressure occurred within 5 minutes of dosing compared to 8 minutes for EpiPen. Maximum mean effects in heart rate occurred within 8 minutes of administering AQST-109 compared to an average of 5 minutes within administering EpiPen.
- Safety results for AQST-109 were in line with expectations, and no severe or serious adverse events were reported.
- End-of-Phase 2 meeting with FDA is scheduled for the fourth quarter of 2022, and the remaining clinical studies will commence after that.
- Price Action: AQST shares are up 8.88% at $1.21 during the market session on the last check Tuesday.
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