Aquestive stock falls 7% amid data from study of oral film AQST-109 for allergies

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Aquestive Therapeutics (NASDAQ: AQST) reported data from Part 2 of its EPIPHAST study of epinephrine oral film AQST-109 being explored for treating severe allergies, including anaphylaxis.

The company said Part 2 of the EPIPHAST study was a replicate design crossover study in 24 healthy people comparing the pharmacokinetic and pharmacodynamic measures of AQST-109 12-mg against epinephrine intramuscular injection 0.3 mg.

The company said the results were aligned with previous positive results reported for AQST-109, and the drug was well tolerated with no serious adverse events.

Aquestive (AQST) noted that AQST-109 showed rapid absorption with favorable pharmacokinetics across several metrics.

The company added that Part 2 also showed maximum concentration (Cmax) values ‚Äč‚Äčthat were consistent with the 0.3mg IM Injection and those previously reported for approved injectable epinephrine devices such as EpiPen.

In addition to positive pharmacokinetic results, AQST-109 showed favorable pharmacodynamic effects on systolic blood pressure, diastolic blood pressure, and heart rate, the company said in an April 12 press release.

The positive results we are reporting today demonstrate the continued performance of AQST-109, the first and only orally delivered epinephrine product candidate, which represents, if approved by the FDA, a potential paradigm shift in the management of severe allergies, including anaphylaxis, “said Aquestive CEO Keith Kendall.

Aquestive plans to begin Part 3 in April and expects to complete EPIPHAST study by the end of Q2 2022.

AQST -7.41% to $ 2.00 premarket April 12

gorodenkoff / iStock via Getty Images Aquestive Therapeutics (NASDAQ: AQST) reported data from Part 2 of its EPIPHAST study of epinephrine oral film AQST-109 being explored for treating severe allergies, including anaphylaxis. The company said Part 2 of the EPIPHAST study was a replicate design crossover study in 24 healthy people comparing the pharmacokinetic and…

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