AQST - Aquestive posts positive topline study data for epinephrine oral film

Aquestive Therapeutics (NASDAQ:AQST) is trading ~6% higher in the premarket Friday after the commercial-stage pharmaceutical company announced positive topline data from its Part 1 of the EPIPHAST study for AQST-109 epinephrine oral film. In the randomized open-label trial involving healthy adults, AQST-109 was compared with intramuscular injection of epinephrine. For lead formulations of AQST-109, the median time to peak concentration stood at 13.5 minutes and 22.5 minutes, respectively, according to the company. In line with the feedback received from the U.S. Food and Drug Administration (FDA) regarding the company’s pre-Investigational New Drug (pre-IND) submission, the trial subjects were also given a 0.5mg intramuscular injection (IM) of epinephrine. The findings indicated that two formulations of AQST-109 can lead to faster delivery of clinically meaningful blood concentrations of epinephrine compared to a higher dose of epinephrine IM injection without the concerns of safety and tolerability, Aquestive (AQST) added. Part 2 of the trial has

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Aquestive posts positive topline study data for epinephrine oral film