Aquestive Therapeutics Announces Publication of Crossover Food Effect Study of Diazepam Nasal Spray in Epilepsia
November 29, 2022 at 08:00 AM EST
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 <0.0001) and the overall diazepam exposure during the first four hours was reduced by 57% (P <0.0001) 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 (P <0.0001). At two hours post-dose, diazepam concentrations were ≥150 ng/mL for 100% of subjects when fasted and 30% when fed.
Michael A. Rogawski, MD, PhD, Professor of Neurology and Pharmacology, School of Medicine, University of California, Davis and lead author, stated, “Diazepam absorption is known to be influenced by food but physicians may assume that food won’t affect diazepam absorption when it is administered by nasal spray. This assumption may not be justified since a portion of a nasal spray is swallowed. This study observed a surprisingly large influence of food on the rate and extent of absorption of diazepam administered via a nasal spray. Since the peak concentration is markedly blunted, diazepam nasal spray may have reduced efficacy when used after a meal.”
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials for AQST-109 and our other product candidates; in approving risk of our ability to demonstrate to the United States Food and Drug Administration (FDA) “clinical superiority” of Libervant™ (diazepam) Buccal Film within the meaning of the FDA regulations relative to the FDA-approved diazepam nasal spray product of an unrelated company competitor in the U.S. in order to overcome orphan drug market exclusivity for seven years of such approved nasal spray product, including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved product, as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity, and there can be no assurance that we will be successful; risk of delays in FDA approval of AQST-109 and our other drug candidates, or failure to receive FDA approval at all; risk in obtaining market access for other reasons; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of our sales and marketing capabilities; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed; risk of the rate and degree of market acceptance of our product and product candidates; risks associated to the success of any competing products, including generics; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks related to legal proceedings and associated costs, including patent infringement, securities, business torts, investigative and antitrust litigation matters; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our Annual Report on Form 10 K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.
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