Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) ...
December 02 2019 - 7:30AM
Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products that meet patients’ unmet needs and solve
therapeutic problems, today announced the completion, as planned,
of the rolling submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for its therapeutic
candidate Libervant™ (diazepam) Buccal Film for the management of
seizure clusters. Libervant has received orphan drug
designation from the FDA.
“We are very pleased to have completed our NDA
filing for Libervant as we had committed. We look forward to
sharing the results from the single dose crossover study at the
upcoming American Epilepsy Society 2019 Annual Meeting. We believe
these results confirm our dosing algorithm and satisfy the final
clinical requirement requested by the FDA,” remarked Keith J.
Kendall, Chief Executive Officer of Aquestive Therapeutics.
“We believe that Libervant has the potential to be the first oral
therapy approved by the FDA for the management of seizure clusters
in the population of 1.2 million refractory epilepsy patients and
the first diazepam based treatment usable by and delivering a
consistent predictable dose to virtually all patients to whom it
will be prescribed.”
About LibervantLibervant is a
buccally, or inside of the cheek, administered soluble film
formulation of diazepam, a benzodiazepine intended for rapid
treatment of acute uncontrolled seizures in selected, refractory
patients with epilepsy on stable regimens of AEDs who require
intermittent use of diazepam to control bouts of increased seizure
activity. Aquestive is developing Libervant as an alternative to
Diastat (diazepam rectal gel), the current standard of care rescue
therapy for patients with refractory epilepsy, which as a rectal
gel, is invasive, inconvenient, and difficult to administer. As a
result, a large portion of the patient population does not receive
adequate treatment or foregoes treatment altogether. It is
anticipated that Libervant will enable a larger share of these
patients to receive more appropriate treatment by providing
consistent therapeutic dosing in a non-invasive and innovative
treatment form for epileptic seizures.
About Aquestive
TherapeuticsAquestive Therapeutics is a specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline to treat CNS
conditions and provide alternatives to invasively administered
standard of care therapies. The Company also collaborates with
other pharmaceutical companies to bring new molecules to market
using proprietary, best-in-class technologies, like PharmFilm®, and
has proven capabilities for drug development and
commercialization.
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. Aquestive has received
conditional acceptance of the use of the trade name Libervant,
which is subject to final FDA review and acceptance.
Forward-Looking StatementThis
press release includes 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 may
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approval of
Libervant and other product candidates; statements about our growth
and future financial and operating results and financial position,
ability to advance Libervant and our other product candidates to
the market, regulatory approvals and pathways, clinical trial
timing and plans, short-term and long-term liquidity and cash
requirements, cash funding and cash burn, business strategies,
market opportunities, and other statements that are not historical
facts.
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; risk of delays in FDA
approval of Libervant and our other drug candidates or failure to
receive approval; risk inherent in commercializing a new product
(including technology risks, financial risks, market risks and
implementation risks and regulatory limitations); risk that a
competitor obtains orphan drug exclusivity and blocks our product
for the same indication for seven years; risk of development of our
sales and marketing capabilities; risk of legal costs associated
with and the outcome of our patent litigation challenging third
party at risk generic sale of our proprietary products; 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 cash requirements
and other cash needs, at the times and in the amounts needed; risk
of failure to satisfy all financial and other debt covenants and of
any default; risk related to government claims against Indivior for
which we license, manufacture and sell Suboxone and which accounts
for the substantial part of our current operating revenues; risks
associated with Indivior’s announcement of its intention to cease
production of its authorized generic buprenorphine naloxone film
product, including the impact from loss of orders for the
authorized generic product and risk of eroding market share for
Suboxone and risk of sunsetting product; risks related to the
outsourcing of certain sales, marketing and other operational and
staff functions to third parties; risk of the rate and degree of
market acceptance of our products and product candidates; the
success of any competing products, including generics; risk of the
size and growth of our product markets; risk 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 action 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,
including patent infringement, investigative and antitrust
litigation matters; changes in governmental 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 risks and
uncertainties affecting the Company including those described in
the "Risk Factors" section and in other sections included in the
Company's Annual Report on Form 10‑K filed with the SEC on
March 14, 2019 and in our quarterly reports on Form 10-Q. Given
these 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.
Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
Media inquiriesMark
Corbaemark.corbae@icrinc.com203-682-8288
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