Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal...
July 19 2021 - 9:29AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today that the U.S. Food and Drug
Administration (FDA) has accepted for filing the resubmission of
the New Drug Application (NDA) for Libervant™ (diazepam) Buccal
Film for the management of seizure clusters. The FDA has assigned a
Prescription Drug User Fee Act (“PDUFA”) target goal date of
December 23, 2021.
“We are pleased with the FDA’s decision to accept for review the
Libervant NDA. We believe this underscores the unmet need in the
underserved population of refractory epilepsy patients for a
non-invasive and innovative product for the management of seizure
clusters,” stated Keith Kendall, Chief Executive Officer of
Aquestive. “We are preparing for the commercial launch of
Libervant, if approved for U.S. market access, in the first half of
2022 and remain committed to fill this unmet need and improve the
quality of life for patients suffering from this disease with this
first of its kind treatment option."
Aquestive received a Complete Response Letter (CRL) from the FDA
in September 2020, completed a Type A meeting with the FDA in
November 2020 and received further guidance from the FDA in
February 2021. Based upon the Agency's guidance, the submission
included additional statistical modeling and supporting analyses of
the existing clinical data. The Company continues to believe that
no additional clinical studies will be required for FDA approval of
Libervant for U.S. market access.
About LibervantThe Company believes that Libervant, if approved
by the FDA for U.S. market access, will enable a larger share of
patients to receive more appropriate treatment by providing
consistent therapeutic dosing in a non-invasive and innovative
treatment form for epileptic seizures. Libervant™ 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.
About Aquestive TherapeuticsAquestive Therapeutics is a
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. The
Company has commercialized one internally-developed proprietary
product to date, Sympazan® (clobazam) oral film, has a commercial
proprietary product pipeline focused on the treatment of diseases
of the central nervous system, or CNS, and other unmet needs, and
is developing orally administered complex molecules to 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.
Forward-Looking StatementThis press release includes
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. For this purpose, 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 regarding the advancement of Libervant,
including our belief that the resubmitted NDA addresses all of the
issues raised in the CRL, through the regulatory and development
pipeline and business strategies, market opportunities, and other
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; risk of delays in FDA approval of
Libervant or failure to receive approval or U.S. market access;
ability to address the concerns identified in the FDA’s CRL for
Libervant; risk of our ability to demonstrate to the FDA “clinical
superiority” within the meaning of the FDA regulations of Libervant
relative to FDA-approved diazepam rectal gel and nasal spray
products including by establishing a major contribution to patient
care within the meaning of FDA regulations relative to the approved
products 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 granted by the FDA
for the approved nasal spray product of a competitor in the U.S.
and there can be no assurance that we will be successful; risk that
a competitor obtains FDA orphan drug exclusivity for a product with
the same active moiety as any of our other drug products for which
we are seeking FDA approval and that such earlier approved
competitor orphan drug blocks such other product candidates in the
U.S. for seven years for the same indication; risk in obtaining
market access for Libervant 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 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; our and our
competitors’ orphan drug approval and resulting drug exclusivity
for our products or products of our competitors; short-term and
long-term liquidity and cash requirements, cash funding and cash
burn; 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
related to the outsourcing of certain marketing and other
operational and staff functions to third parties; risk of the rate
and degree of market acceptance of our product and product
candidates; 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,
including patent infringement, 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 (SEC). 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 Westwicke, an ICR Company Stephanie
Carrington stephanie.carrington@westwicke.com 646-277-1282
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