Aquestive Therapeutics announces publication of crossover food effect study

Aquestive Therapeutics announced the publication of a crossover food effect pharmacokinetic study of diazepam nasal spray in the peer-reviewed scientific journal Epilepsia. The study was sponsored by Aquestive in 2021 and conducted by an accredited independent clinical research organization. It was included by Aquestive as part of its New Drug Application for Libervant Buccal Film that was submitted to the U.S. Food & Drug Administration. The randomized, open-label crossover study compared equal doses of diazepam nasal spray after an overnight fast and after a standardized high-fat, high-calorie breakfast. Under fed conditions, the mean maximum plasma diazepam concentration was decreased by 48% and the overall diazepam exposure during the first four hours was reduced by 57% compared with fasted conditions. The time to maximum plasma concentration was 4.0 hours in the fed state, compared with 2.0 hours in the fasted state. At two hours post-dose, diazepam concentrations were greater than or equal to150 ng/mL for 100% of subjects when fasted and 30% when fed.