Aquestive Therapeutics Announces Publication of Crossover Food Effect Study of Diazepam Nasal Spray in Epilepsia
30 November 2022 - 12:00AM
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.”
PublicationRogawski MA, Slatko G. A Randomized,
Open-Label, Two-Treatment Crossover Study to Evaluate the Effect of
Food on the Pharmacokinetics of Diazepam Nasal Spray in Healthy
Adult Subjects. Epilepsia. 2022 Nov 22;
https://doi.org/10.1111/epi.17459
About AquestiveAquestive
Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company
advancing current standards of care to solve patients’ problems by
simplifying complex delivery methods. Aquestive is developing
pharmaceutical products to deliver complex molecules through
alternative administrations to invasive and inconvenient standard
of care therapies. Aquestive has five licensed commercialized
products which are marketed by our licensees in the U.S. and around
the world. The Company is the exclusive manufacturer of these
licensed products. The Company also collaborates with
pharmaceutical companies to bring new molecules to market using
proprietary, best-in-class technologies, like PharmFilm®, and has
proven drug development and commercialization capabilities. The
Company is advancing an early stage product pipeline for the
treatment of severe allergic reactions, including anaphylaxis. The
Company has also developed a product pipeline focused on treating
diseases of the central nervous system, or CNS. The Company's
production facilities are located in Portage, Indiana, and our
corporate headquarters, sales and commercialization operations and
primary research laboratory facilities are based in Warren, New
Jersey. For more information, visit Aquestive.com and
follow us on LinkedIn.
Forward-Looking Statement
Certain statements in this press release include “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,”
“expect,” “estimate,” “intend,” “may,” “will,” or the negative of
those terms, and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements
include, but are not limited to, statements that are not historical
facts. These forward-looking statements are subject to the
uncertain impact of the COVID-19 global pandemic on our business
including with respect to our clinical trials including site
initiation, patient enrollment and timing and adequacy of clinical
trials; on regulatory submissions and regulatory reviews and
approvals of our product candidates; pharmaceutical ingredient and
other raw materials supply chain, manufacture, and distribution;
sale of and demand for our products; our liquidity and availability
of capital resources; customer demand for our products and
services; customers’ ability to pay for goods and services; and
ongoing availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is unable to
provide assurance that operations can be maintained as planned
prior to the COVID-19 pandemic.
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.
PharmFilm®, Sympazan® and the Aquestive logo are
registered trademarks of Aquestive Therapeutics, Inc. All other
registered trademarks referenced herein are the property of their
respective owners.
Investor Inquiries:ICR Westwicke Stephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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