Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Contraceptive Patch, Twirla®
June 27 2017 - 7:00AM
Agile Therapeutics, Inc., (NASDAQ:AGRX), a women’s healthcare
company, today announced it has resubmitted to the U.S. Food and
Drug Administration (FDA) the NDA for its lead product candidate,
Twirla®, an investigational low-dose combined hormonal
contraceptive patch (AG200-15). Agile resubmitted the NDA in
response to a February 2013 Complete Response Letter (CRL) from the
FDA, which recommended that Agile conduct a new clinical trial and
provide additional information on the manufacturing process for
Twirla. The resubmitted NDA includes efficacy and safety data from
the new Phase 3 clinical trial (also known as the SECURE trial),
the requested manufacturing information, and a summary response to
the CRL.
“We have resubmitted our NDA for Twirla as
planned and look forward to working with the FDA during the review
process,” said Al Altomari, Chairman and Chief Executive Officer of
Agile. “Our achievement of this milestone reflects our
commitment to changing the paradigm of available contraceptive
treatment options for today’s women and brings us one step closer
to commercializing our low-dose contraceptive patch and offering an
option to women seeking novel methods best suited to their needs
and lifestyle. Once the FDA has acknowledged our submission
as a complete response, we expect to receive a Prescription Drug
User Fee Act (PDUFA) date that we anticipate will be based on a
six-month review.”
About Agile Therapeutics,
Inc.
Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product candidates are designed to provide
women with contraceptive options that offer freedom from taking a
daily pill, without committing to a longer-acting method. Our lead
product candidate, Twirla®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch that recently completed Phase 3
trials. Twirla is based on our proprietary transdermal patch
technology, called Skinfusion®, which is designed to provide
advantages over currently available patches and is intended to
optimize patch adhesion and patient wearability. For more
information, please visit the company website at
www.agiletherapeutics.com. The company may occasionally disseminate
material, nonpublic information on the company website.
Forward-Looking Statement
Certain information contained in this press
release includes "forward-looking statements" related to the
Company's regulatory submissions. We may, in some cases use terms
such as "predicts," "believes," "potential," "continue,"
"anticipates," "estimates," "expects," "plans," "intends," "may,"
"could," “might," "will," "should" or other words that convey
uncertainty of the future events or outcomes to identify these
forward-looking statements. Our forward-looking statements are
based on current beliefs and expectations of our management team
that involves risks, potential changes in circumstances,
assumptions and uncertainties. Any or all of the forward-looking
statements may turn out to be wrong, or be affected by inaccurate
assumptions we might make or by known or unknown risks and
uncertainties. Our statements about the results and conduct of our
clinical trial could be affected by the potential that there are
changes in the data or interpretation of the data by the FDA (for
example, the FDA may include additional pregnancies in its
calculation of the Pearl Index, which would increase the Pearl
Index), whether the results will be deemed satisfactory by the FDA
(for example, we may describe the results of the SECURE trial as
positive, the FDA may disagree with that characterization), and
whether additional studies will be required or other issues will
arise that will negatively impact acceptance, review and approval
of Twirla by the FDA; the FDA may delay its review longer than we
expect; and our statements about the potential commercial
opportunity could be affected by the potential that our product
does not receive regulatory approval, does not receive
reimbursement by third-party payors, or a commercial market for the
product does not develop because of any of the risks inherent in
the commercialization of contraceptive products. For all
these reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. All forward-looking statements are subject to risks
detailed in our filings with the U.S. Securities and Exchange
Commission, including the Company's Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q. You are cautioned not to place
undue reliance on these forward-looking statements, which are made
only as of the date of this press release. We undertake no
obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
Investor Relations Contact:
Mary Coleman
Agile Therapeutics
609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
Historical Stock Chart
From Apr 2024 to May 2024
Agile Therapeutics (NASDAQ:AGRX)
Historical Stock Chart
From May 2023 to May 2024