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Aquestive Therapeutics (NASDAQ:AQST) reported information from Half 2 of its EPIPHAST research of epinephrine oral movie AQST-109 being explored for treating extreme allergy symptoms, together with anaphylaxis.
The corporate mentioned Half 2 of the EPIPHAST research was a replicate design crossover research in 24 wholesome folks evaluating the pharmacokinetic and pharmacodynamic measures of AQST-109 12-mg towards epinephrine intramuscular injection 0.3 mg.
The corporate mentioned the outcomes have been aligned with earlier constructive outcomes reported for AQST-109, and the drug was effectively tolerated with no severe opposed occasions.
Aquestive (AQST) famous that AQST-109 confirmed speedy absorption with favorable pharmacokinetics throughout a number of metrics.
The corporate added that Half 2 additionally confirmed most focus (Cmax) values that have been in keeping with the 0.3mg IM Injection and people beforehand reported for authorised injectable epinephrine units equivalent to EpiPen.
Along with constructive pharmacokinetic outcomes, AQST-109 confirmed favorable pharmacodynamic results on systolic blood stress, diastolic blood stress, and coronary heart fee, the corporate mentioned in an April 12 press launch.
“The constructive outcomes we’re reporting immediately reveal the continued efficiency of AQST-109, the primary and solely orally delivered epinephrine product candidate, which represents, if authorised by the FDA, a possible paradigm shift within the administration of extreme allergy symptoms, together with anaphylaxis,” mentioned Aquestive CEO Keith Kendall.
Aquestive plans to start Half 3 in April and expects to finish EPIPHAST research by the tip of Q2 2022.
AQST -7.41% to $2.00 premarket April 12
