Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla®
17 5월 2019 - 8:30PM
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 December 2017 Complete Response Letter (CRL) from the
FDA, which identified deficiencies relating to (i) quality control
adhesion test methods for the Twirla manufacturing process, (ii)
observations identified during an inspection of a facility of our
third-party manufacturer for the Twirla NDA that must be resolved,
and (iii) questions on the in vivo adhesion properties of Twirla
and their potential relationship to the SECURE clinical trial
results. The resubmitted NDA includes the results from a
comparative wear study that was conducted at the request of the FDA
to address the FDA’s questions on in vivo adhesion, additional
information on the Company’s manufacturing process, and other
analyses responding to the 2017 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 broadening the available contraceptive treatment
options for today’s women by offering an option to women seeking
methods best suited to their needs and lifestyle. We expect
the FDA to acknowledge our submission as a complete response in
approximately thirty days, and at the same time provide us with 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 an investigational low-dose, non-daily prescription
contraceptive. Twirla is based on our proprietary transdermal patch
technology, called Skinfusion®, which is designed to allow drug
delivery through the skin. For more information, please visit the
company website at www.agiletherapeutics.com. The Company may
occasionally disseminate material, nonpublic information on the
Company’s website.
Forward-Looking Statement
Certain information contained in this press
release includes “forward-looking statements”, within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended,
related to our regulatory submissions for Twirla. We may, in some
cases use terms such as “predicts,” “believes,” “potential,”
“continue,” “anticipates,” “estimates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “likely,” “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 involve risks, potential
changes in circumstances, assumptions, and uncertainties, including
statements regarding the FDA’s acknowledgement of the resubmission
of the Twirla NDA as a complete response, the timing of such
acknowledgement and our expectations regarding the receipt of a
PDUFA date and the timing of such date. 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. These forward looking statements are
subject to risks and uncertainties including risks related to our
ability to adequately and timely respond to the deficiencies in the
second Twirla CRL issued by the FDA on December 21, 2017, the
potential that the FDA determines that our resubmitted NDA is not a
complete response and refuses to review the NDA, or that our data
do not support resubmission or approval of Twirla NDA and requires
us to conduct additional studies or reformulate Twirla to address
the concerns raised in the 2017 CRL, our ability to obtain and
maintain regulatory approval of our product candidates, the
labeling under any approval we may obtain, our ability to obtain a
favorable Advisory Committee vote in the likely event the FDA
requires an Advisory Committee to review the benefit and risk
profile of Twirla, our third-party manufacturer, Corium
International, Inc.’s (Corium) inability to complete any work or
provide any data and other information necessary to support the
resubmission and approval of our Twirla NDA, our ability along with
Corium to complete successfully the scale-up of the commercial
manufacturing process for Twirla, including the qualification and
validation of equipment related to the expansion of Corium's
manufacturing facility and to pass a likely FDA pre-approval
inspection, the performance and financial condition of Corium or
any of the suppliers to our third-party manufacturer, the success
and timing of our clinical trials or other studies, regulatory and
legislative developments in the United States and foreign
countries, our ability to obtain and maintain intellectual property
protection for our product candidates, our inability to timely
obtain from our third-party manufacturer, Corium, sufficient
quantities or quality of our product candidates or other materials
required for a clinical trial or other tests and studies, and the
other risks set forth in our filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q. For all these reasons,
actual results and developments could be materially different from
those expressed in or implied by our forward-looking statements.
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.
Source: Agile Therapeutics
Contact: Investor Relations --
609-683-1880
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