PRINCETON, N.J., Oct. 16, 2017 /PRNewswire/ -- Agile
Therapeutics, Inc., (NASDAQ: AGRX), a women's healthcare company,
today announced the presentation of additional results from the
Phase 3 SECURE trial of its investigational low-dose combination
hormonal contraceptive patch, Twirla® (AG200-15). Anita Nelson, MD, Professor and Chair of
Obstetrics and Gynecology at the College of Osteopathic Medicine of
the Pacific, presented new data on the Twirla bleeding profile
during a poster presentation at the 2017 National Association for
Family Planning (NAFFP), "The Forum" in Atlanta, GA.
The poster presentation provided detailed analyses on scheduled
(withdrawal) and unscheduled (breakthrough) bleeding and/or
spotting episodes. Rates of unscheduled bleeding and/or
spotting decreased during the study period. Similarly, the
mean length of both unscheduled and scheduled bleeding and/or
spotting episodes decreased during the study period. Few
subjects discontinued from the trial for bleeding-related issues,
and rates of unscheduled bleeding and/or spotting decreased over
the 12-month study period.
The Phase 3 SECURE trial was a multicenter, single-arm,
open-label, 13 cycle trial designed to evaluate the efficacy,
safety and tolerability of Twirla in 2032 healthy women, aged 18
years and over, at 102 investigational sites across the United States. Bleeding information was
self-reported by subjects on a daily basis in electronic diaries.
Subjects were asked about both scheduled and unscheduled bleeding
and spotting, using definitions described by Mishell et al
(Recommendations for Standardization of Data Collection and
Analysis of Bleeding in Combined Hormone Contraceptive Trials;
Contraception 75; 11-15).
Dr. Nelson commented, "The use of electronic diaries to collect
daily bleeding data during the SECURE trial has yielded a robust
package of data on the bleeding profile of Twirla. These new
analyses provide information that will be very helpful to providers
to guide counseling of patients considering use of the Twirla
patch, if approved."
For more information, please visit the company website at
www.agiletherapeutics.com.
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 Statement
Certain 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 involves 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 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; our statements about the potential commercial opportunity
could be affected by the potential that our product does not
receive regulatory approval, does not receive reimbursement by
third party payors, or a commercial market for the product does not
develop because of any of the risks inherent in the
commercialization of contraceptive products; 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.
Investor Relations Contact:
Mary Coleman
Agile Therapeutics
609-356-1921
PR Contact:
Kristin
Pehush
Lippe Taylor
212-598-4400
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SOURCE Agile Therapeutics, Inc.