Agile Therapeutics Announces Presentation of SECURE Phase 3 Data at the 2017 Congress on Women’s Health
27 4월 2017 - 8:30PM
Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare
company announced today that a presentation entitled “An Update on
Hormonal Contraception and The Changing U.S. Population” will be
presented by Co-Principal Investigator of the SECURE clinical
trial, Anita Nelson, MD, Professor and Chair, Obstetrics and
Gynecology, College of Osteopathic Medicine of the Pacific at the
25th Anniversary Congress on Women’s Health, jointly sponsored by
the Academy of Women’s Health and Journal of Women’s Health, on
April 29, 2017 at 7:00am ET at the Crystal Gateway Marriott in
Arlington, VA. The presentation will focus on real-world
contraceptive study design and outcomes.
The presentation will include data from the
Phase 3 clinical trial evaluating Twirla®, also known as the SECURE
clinical trial. SECURE was a one-year, multicenter,
single-arm, open-label trial that evaluated the safety, efficacy
and tolerability of Twirla in 2032 healthy women, aged 18 and over,
at 102 experienced investigative sites across the United
States. Agile announced top-line results of the SECURE
clinical trial in January 2017.
The Company plans to resubmit its new drug
application for Twirla to the U.S. Food and Drug Administration by
the end of the second quarter of 2017.
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
StatementCertain 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 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 planned resubmission of our NDA for Twirla
could be affected by the potential that additional analyses of
issues identified in our complete response letter from the FDA are
required to be completed that were not previously anticipated, that
our ongoing tests to support our resubmission are not completed on
time, that the third parties we rely on to perform services in
support of our NDA resubmission do not complete their work in a
timely fashion and that 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 -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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