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- Aquestive Therapeutics Inc (NASDAQ: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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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