Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission for Libervant™ (diazepam) Buccal Film Following FDA Feedback
February 25 2021 - 7:30AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, today announced that the Food and Drug Administration
(FDA) has provided further guidance to Aquestive regarding the
information to be included in the New Drug Application (NDA) for
Libervant™ (diazepam) Buccal Film for the management of seizure
clusters. The further guidance from the FDA addresses the revised
weight-based dosing regimen, modeling and simulations data that
Aquestive provided to the Agency in December 2020.
“We have a clear path to resubmitting our NDA
for Libervant and expect to do so around the end of the second
quarter of 2021. The Agency provided additional guidance and
clarity regarding information and supporting analysis that should
be included in our resubmission,” said Keith Kendall, President and
Chief Executive Officer of Aquestive. “We believe our focus on
engaging in multiple communications with the FDA prior to
resubmitting our application will ultimately result in a
collaborative review process and we look forward to continuing our
interactions with the FDA.”
The FDA’s written feedback provided direction on
the FDA’s expectations for the information and supporting analysis
relating to the population pharmacokinetic model, which the Company
will be working to provide in a form acceptable to the FDA.
Aquestive is aligned with the FDA’s expectations and will include
the requested information in its upcoming resubmission of the NDA
for Libervant. In addition, the FDA provided guidance on its
expectations around the nature and format of safety data that
should be included in the resubmission.
Aquestive received a Complete Response Letter
(CRL) from the FDA on September 25, 2020 and subsequently completed
a Type A meeting with the FDA in November of 2020. Based on the
FDA’s feedback at the Type A meeting, as well as this further
guidance from the Agency, Aquestive continues to believe that no
further clinical studies are necessary for the resubmission of the
NDA for Libervant. Once resubmitted, Aquestive anticipates a six
month review process.
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. The Company
believes 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 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
StatementsCertain statements in this press release are
“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 regarding the advancement of Libervant through the FDA
regulatory approval process for U.S. market access; that the FDA
review process will be collaborative; that clinical trials will not
be necessary to obtain approval from the FDA; 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. 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, the
risk that the resubmission of the NDA for Libervant to the FDA will
not be satisfactory; that unforeseen factors will delay the
resubmission of the NDA for Libervant; the possibility that
clinical trials will in fact be necessary to advance Libervant for
FDA approval for U.S. market access; risks of delays in or failure
to obtain FDA approval of Libervant; risks of the Company’s ability
to address the concerns identified in the FDA’s Complete Response
Letter dated September 25, 2020 regarding the NDA for Libervant or
subsequent communications with the FDA; 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 will
obtain other market exclusivity with respect to our products; risks
associated with the Company's development work, including any
delays or changes to the timing; 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; risks related to legal proceedings, including
patent infringement, investigative and antitrust litigation
matters; changes in government laws and regulations; risks 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
CompanyStephanie
Carringtonstephanie.carington@westwicke.com646-277-1282
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