Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla®
May 22 2019 - 7:00AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare
company, today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the Company’s New Drug
Application (NDA) resubmission for Twirla® (AG200-15), an
investigational low-dose combined hormonal contraceptive
patch. The NDA resubmission was submitted on May 16, 2019 and
is intended to address a Complete Response Letter (CRL) issued by
the FDA in December 2017, 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. The FDA
stated that it considers the resubmission to be a complete, class 2
response to the CRL and established November 16, 2019 as the
Prescription Drug User Fee Act (PDUFA) goal date.
“The acceptance of our NDA for review represents
a significant milestone for Agile. Now that the FDA has
acknowledged our NDA resubmission as a complete response to the
CRL, we look forward to continuing to work with the FDA during
their review,” said Al Altomari, Chairman and Chief Executive
Officer of Agile.
About Agile Therapeutics
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.
About Twirla® Twirla (ethinyl
estradiol and levonorgestrel transdermal system), or AG200-15, is
an investigational once-weekly prescription contraceptive patch.
AG200-15 is a combined hormonal contraceptive (CHC) patch that
contains the active ingredients ethinyl estradiol (EE), a synthetic
estrogen, and levonorgestrel (LNG), a type of progestin, a
synthetic steroid hormone. Twirla is designed to be applied once
weekly for three weeks, followed by a week without a patch.
Forward-Looking
StatementCertain 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 acknowledgment of the resubmission of the Twirla NDA as a
complete response, the timing of such acknowledgment 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 TherapeuticsContact:
Investor Relations -- 609-683-1880
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