WARREN, N.J., Nov. 16, 2018 /PRNewswire/ -- Aquestive
Therapeutics, Inc. (NASDAQ: AQST) today announced it received a
complete response letter (CRL) from the U.S. Food and Drug
Administration (FDA) in regards to its New Drug Application (NDA)
for tadalafil oral film (OF). Tadalafil is a PDE5 inhibitor
currently marketed in tablet form for the treatment of erectile
dysfunction and benign prostatic hyperplasia (BPH) under the brand
name Cialis®, and for treatment of pulmonary arterial
hypertension under the brand name Adcirca®.
In the letter, the FDA requested limited additional data from
healthy volunteers. The company has also notified the agency about
its plans to engage an alternative supplier of the active
pharmaceutical ingredient (API).
"The matters cited in the CRL are unique to the oral film
formulation of tadalafil, and do not affect any other products that
Aquestive develops, markets or manufactures. The comments provided
in the CRL are manageable and we will work with the FDA to map out
our path to resubmission and approval," said Keith J. Kendall, Chief Executive Officer of
Aquestive Therapeutics. "We continue to see a pathway to tentative
approval before the expiry of the patents for the reference
product. We anticipate partnering tadalafil OF once approved and
the CRL has not changed our timing or intent."
About Aquestive Therapeutics
Aquestive
Therapeutics is a specialty pharmaceutical company committed
to identifying, developing and commercializing differentiated
products to address unmet medical needs. Aquestive
Therapeutics has a late-stage proprietary product pipeline
focused on the treatment of CNS diseases, and is working to advance
orally-administered complex molecules that it believes can be
alternatives to invasively-administered standard of care therapies.
As the leader in developing and delivering drugs via its
PharmFilm® technology, Aquestive
Therapeutics also collaborates with pharmaceutical partners to
bring new molecules to market in differentiated and
highly-marketable dosage forms.
Forward-Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as
"anticipate," "believe," "could," "estimate," "expects," "intend,"
"may," "plan," "potential," "project," "will," "would," or the
negative of those terms, and similar expressions, are intended to
identify forward-looking statements. Such statements include, but
are not limited to, statements about regulatory approvals and
pathways, clinical trial timing and plans, the achievement of
clinical and commercial milestones, future financial and operating
results, business strategies, market opportunities, financing, 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; the risks of delays in FDA approval
of our drug candidates or failure to receive approval; the risks
inherent in commercializing a new product (including technology
risks, financial risks, market risks and implementation risks and
regulatory limitations); development of our sales and marketing
capabilities; the rate and degree of market acceptance of our
product candidates; the success of any competing products; the size
and growth of our product markets; the effectiveness and safety of
our product candidates; risks associated with intellectual property
rights and infringement; unexpected patent developments; and other
risks and uncertainties affecting the Company including those
described in the "Risk Factors" section included in our
Registration Statement on Form S-1 declared effective by the SEC on
July 24, 2018. As with any
pharmaceutical product candidate under development, there are
significant risks with respect to the development, regulatory
approval and commercialization of new products. 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. We assume no obligation to
update our forward-looking statements after the date of this press
release whether as a result of new information, future events or
otherwise, except as may be required under applicable law.
Media inquiries:
Christopher Hippolyte
christopher.hippolyte@syneoshealth.com
212-364-0458
Investor inquiries:
Stephanie Carrington
stephanie.carrington@icrinc.com
646-277-1282
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SOURCE Aquestive Therapeutics