Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company advancing medicines to solve patients’ problems with
current standards of care and provide transformative products to
improve their lives, today announced positive topline results from
the EPIPHAST II trial for its AQST-109 epinephrine sublingual film.
“Speed matters in delivering systemic
epinephrine during an anaphylaxis event. Any delay can result in
severe bronchospasm, acute respiratory failure and/or
cardiovascular collapse, as well as less favorable outcomes and
death,” said David Bernstein, MD, University of Cincinnati.
“AQST-109 continues to demonstrate fast delivery of therapeutic
levels which are necessary to stop anaphylaxis at an early stage
and prevent progression to a more severe reaction.”
The EPIPHAST II trial was designed to compare
single doses of AQST-109 to EpiPen® 0.3mg and epinephrine 0.3mg
intramuscular (IM) injection, as well as repeat doses of AQST-109
to repeat doses of epinephrine 0.3mg IM injection. Results from the
single dose administration showed AQST-109 achieved a significantly
faster Tmax (12 minutes), compared to both EpiPen® (22.5 minutes)
and epinephrine 0.3mg IM injection (45 minutes). AQST-109 repeat
dosing provided significantly higher drug plasma concentrations,
with a Tmax of 8 minutes after administration, and extensive
absorption was observed. The mean maximum concentration (Cmax) of
AQST-109 was 465 pg/mL after one dose and 2,958 pg/mL after two
doses. In comparison, the epi 0.3mg IM injection Cmax was 489 pg/mL
after one dose and 911 pg/mL after two doses. The single dose of
EpiPen resulted in a Cmax of 869 pg/mL.
After one dose of AQST-109, maximum mean effects
on systolic blood pressure occurred within 5 minutes of dosing
compared to 8 minutes for EpiPen. Maximum mean effects in heart
rate occurred within 8 minutes of administering AQST-109 compared
to an average of 5 minutes within administering EpiPen. Safety
results for AQST-109 were in line with expectations, and no severe
or serious adverse events were reported.
“We are pleased to see that AQST-109 compared
favorably to both the EpiPen and the epi 0.3mg IM injection across
several measures,” said Daniel Barber, Chief Executive Officer of
Aquestive. “This is a meaningful step forward for this program and
brings us closer to improving the lives of people who are looking
for alternatives to the current standard of care for allergic
reactions. Literature suggests that over 40 million Americans are
at risk for acute anaphylactic episodes. Yet, over half of those
who have experienced anaphylaxis have never received an epinephrine
auto-injector prescription. We believe AQST-109 will provide a
meaningful addition to treating anaphylaxis and we look forward to
sharing the full dataset with the FDA, which will be the basis for
our end-of-Phase 2 meeting scheduled for the fourth quarter of
2022.”
Today’s Conference Call and
WebcastManagement will host a conference call for
investors at 8:00 a.m. ET on Tuesday, September 27, 2022. In order
to participate, please register here in advance to obtain a local
or toll-free phone number and your personal pin.
The live webcast will be available on the
Investors section of the Company’s website at
https://investors.aquestive.com/events-and-presentations. The
webcast will be archived for 30 days.
About AnaphylaxisAnaphylaxis is
a serious systemic hypersensitivity reaction with rapid onset and
potentially fatal. As many as 49 million people in the United
States are at chronic risk for anaphylaxis. Lifetime prevalence is
at least 5%, or more than 16 million people in the United States.
Direct costs of anaphylaxis have been estimated at $1.2 billion per
year, with direct expenditures of $294 million for epinephrine, and
indirect costs of $609 million. The frequency of hospital
admissions for anaphylaxis has increased 500-700% in the last 10-15
years. 52% of patients, who previously experienced anaphylaxis, had
never received an epinephrine autoinjector prescription, and 60%
did not have an autoinjector currently available. The most common
causes of anaphylaxis are foods (such as peanuts), venom from
insect stings, and medications. Epinephrine injection is the
current standard of treatment intended to reverse the severe
manifestation of anaphylaxis, which may include skin rash, throat
swelling, respiratory problems, gastrointestinal distress, and loss
of consciousness.
About AQST-109AQST-109 is a
polymer matrix-based epinephrine prodrug administered as a
sublingual film that is applied under the tongue for the rapid
delivery of epinephrine. The product is similar in size to a
postage stamp, weighs less than an ounce, and begins to dissolve on
contact. No water or swallowing is required for administration. The
packaging for AQST-109 is thinner and smaller than an average
credit card, can be carried in a pocket, and is designed to
withstand weather excursions such as exposure to rain and/or
sunlight.
About Aquestive
TherapeuticsAquestive Therapeutics, Inc. (NASDAQ:
AQST) is a pharmaceutical company advancing medicines to solve
patients’ problems with current standards of care and provide
transformative products to improve their lives. We are developing
orally administered products to deliver complex molecules,
providing novel alternatives to invasive and inconvenient standard
of care therapies. Aquestive has five commercialized products on
the U.S. market, four licensed products and one stand-alone
proprietary product to date, Sympazan® (clobazam) oral film for the
treatment of seizures associated with Lennox-Gastaut syndrome. Our
licensees market their products in the U.S. and around
the world. 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. Aquestive is
advancing a late-stage proprietary product pipeline focused on
treating diseases of the central nervous system, or CNS, and an
earlier stage pipeline for the treatment of severe allergic
reactions, including anaphylaxis. For more information,
visit Aquestive.com and follow us on LinkedIn.
Forward Looking
StatementCertain 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 regarding the advancement and related timing of AQST-109
through the regulatory and development pipeline and clinical 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 for AQST-109 and our
other product candidates; risk of delays in FDA approval of
AQST-109, Libervant™ (diazepam) Buccal Film and our other drug
candidates or failure to receive FDA approval; ability to address
the concerns identified in the FDA’s Complete Response Letter dated
September 25, 2020 regarding the New Drug Application 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 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; 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
and associated costs, 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.
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 InquiriesICR WestwickeStephanie
CarringtonStephanie.carrington@westwicke.com646-277-1282
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