Aquestive CEO departs with long-awaited seizure drug in FDA limbo

May 18, 2022

Aquestive Therapeutics' president and CEO, Keith Kendall, is departing effective immediately, leaving the approval application for the company's seizure drug in FDA hands.

Kendall, who joined NJ-based Aquestive as CFO shortly after the company was formed, will be replaced by current COO and long-tenured exec, Daniel Barber.

Aquestive was anticipating an FDA decision on its approval application for Libervant in breakthrough seizures and seizure clusters by the end of last year. But just days before the Dec. 23rd PDUFA date, the agency delayed the decision — requesting no additional information — and provided no estimate on the timing of expected action.

Libervant is a soluble film formulation of diazepam, administered inside the cheek. Aquestive was initially handed a CRL for Libervant's NDA back in Sept. 2020, with the FDA citing concerns over certain weight groups showing a lower drug exposure level than desired. Aquestive, armed with more data on PK modeling, resubmitted in July 2021.

Barber will inherit the Libervant delay, as well as an ongoing phase 1 study for AQST-109, a polymer matrix-based film that can be applied under the tongue for the rapid delivery of epinephrine. The company expects to complete the EPIPHAST study by the summer of 2022.

Kendall, through a consulting agreement, will assist in the CEO transition and the execution of the company’s business strategy and operations until the end of the year.