Peer-reviewed data indicates that food significantly decreases and delays the absorption of diazepam dosed via nasal spray
WARREN, N.J., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, announced today 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 (NDA) for Libervant™ (diazepam) Buccal Film that was submitted to the U.S. Food & Drug Administration (FDA).
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. Each subject served as their own control, and there was a washout period of at least 21 days between treatments. Under fed conditions, the mean maximum plasma diazepam concentration was decreased by 48% (P