Agile Therapeutics Announces a Poster Presentation of its SECURE Phase 3 Study at the Contraceptive Technology 2017 Conferenc...
March 16 2017 - 4:30PM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare
company, announced a poster presentation of data from the SECURE
Phase 3 clinical trial for its lead product candidate, Twirla®,
(ethinyl estradiol and levonorgestrel transdermal system), also
known as AG200-15. The poster, titled “The SECURE Study, a
Real-World Trial of a Low-Dose Contraceptive Patch: Addressing the
Changing U.S. Population,” will be presented at the Contraceptive
Technology Conferences on March 16 - 18, 2017 in San
Francisco, CA and March 29 - April 1, 2017 in Boston, MA. The
first author is Anita Nelson, MD, one of the co-primary
investigators for the SECURE trial.
The SECURE study was designed to evaluate the
efficacy, safety, and tolerability of Twirla in a representative
U.S. population of women seeking birth control. SECURE was a
one-year, multicenter, single-arm, open-label trial in 2032 healthy
women aged 18 and over, at 102 experienced investigative sites
across the United States.
The Company plans to resubmit its new drug
application (“NDA”) for Twirla in the first half of 2017.
The Company has filed the poster presentation on
a form 8-K with the U.S. Securities Exchange Commission (“SEC”),
which can be accessed either from the Company’s website or the
SEC’s website.
About Agile TherapeuticsAgile
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" 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 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 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; 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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