Agile Therapeutics Announces Results of its Pre-Submission Meeting with FDA
April 11 2017 - 7:00AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare
company, today announced it has received the final meeting minutes
from its recent New Drug Application (NDA) pre-submission meeting
with the U.S. Food and Drug Administration (FDA) for its lead
product candidate, Twirla®, an investigational low-dose combined
hormonal contraceptive patch. Based on the feedback from the FDA,
Agile believes it has the necessary information to complete the
resubmission of its NDA, which is expected to be submitted by the
end of the second quarter of 2017.
The Company reported top-line results from its
Phase 3 SECURE clinical trial in January 2017, and plans to prepare
the resubmission of its NDA for Twirla based primarily on the
results from the SECURE trial.
Agile requested the meeting with the FDA, which
took place on March 14, 2017, in order to share preliminary data
from the SECURE trial, including key safety data and BMI-related
efficacy findings, and to seek FDA input as to whether the trial
results constitute a basis for addressing the clinical deficiencies
cited in the FDA’s prior Complete Response Letter (CRL).
Agile also requested feedback on whether the proposed NDA content
will meet the FDA’s requirements for submission.
The FDA indicated that based on the preliminary
information provided by the Company, the SECURE trial results
appear acceptable for resubmission. The FDA provided responses to
the Company regarding the presentation of efficacy, safety and
clinical pharmacology analyses in the NDA and requested that
subgroup analysis of efficacy by body weight be provided. The
FDA also provided feedback on the Company’s proposed approach to
the FDA’s other questions in the CRL, including those questions
relating to analysis to support manufacturing controls and release
specifications and use of laser etching on the Twirla patches.
Pre-submission meetings with the FDA are
typically requested by a sponsor company and intended to provide a
sponsor company the opportunity to ask the FDA process questions
about a company’s planned NDA submission, not to discuss the
potential for approval. Therefore, the FDA did not provide
the Company any feedback on whether the results of the SECURE trial
and the contents of the planned, resubmitted NDA will be sufficient
to obtain regulatory approval of Twirla. Consistent with
other NDAs, product labeling will be addressed as part of the FDA’s
review of the resubmitted NDA and will be based on the product’s
overall efficacy and safety profile.
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 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.
Forward-Looking
StatementCertain information contained in this press
release includes "forward-looking statements" related to the
Company's clinical trials and 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," “appears” 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. Any or all
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, while 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 delay resubmission of
our NDA or negatively impact acceptance, review and approval of
Twirla by the FDA, or potentially delay commercial launch of
Twirla. 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.
Contact: Mary Coleman 609-683-1880
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