Abstract on AG200-15 (Twirla®) Accepted for Presentation at the APhA 2018 Annual Meeting & Exposition
14 3월 2018 - 8:45PM
Agile Therapeutics, Inc., (Nasdaq:AGRX), a women's healthcare
company today announced that an abstract related to the Phase 3
SECURE study for AG200-15 (Twirla®), an investigational,
once-weekly, low-dose hormonal contraceptive patch, has been
accepted as a poster presentation at the upcoming APhA 2018
(American Pharmacists Association) Annual Meeting & Exposition,
which will be held from March 16 – 19, 2018 in Nashville, TN.
The poster will include a summary of efficacy
and safety along with the results of the bleeding and
wearability/tolerability profile from the SECURE study as
previously reported.
The presentation details are as follows:
Poster Title: Results from the SECURE trial, a
Phase 3 Study of the AG200-15 Investigational Transdermal
Contraceptive PatchPoster ID:
231Room: Exhibit Hall C-D, Music City
CenterDate and Time: Saturday, March 17,
9:00am-6:00pm and Sunday, March 18, 9:00am-3:00pm
The Phase 3 SECURE study was a multicenter,
single-arm, open-label, 13 cycle trial designed to evaluate the
efficacy, safety and tolerability of AG200-15, also known as
Twirla, in 2032 healthy women, aged 18 years and over, at 102
investigational sites across the United States. The SECURE study
design included a number of stringent elements, including exclusion
of treatment cycles for use of back-up contraception and for lack
of sexual activity. The study also had broad entry criteria, placed
no limitations on BMI or other demographic factors during
enrollment, and enrolled a large and diverse patient population in
order to allow efficacy to be assessed across different, real-world
groups, as requested by the FDA. These entry criteria resulted in
the inclusion of a substantial number of women with a high BMI, who
have frequently been underrepresented in past contraceptive
studies.
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® (levonorgestrel/ethinyl estradiol transdermal
system) or AG200-15, is a 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 while optimizing patch adhesion and comfort for
the patient.
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. Follow Agile on LinkedIn and
Twitter: @AgileTher.
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," “designed,” "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
of our clinical trial could be affected by the potential that there
are changes in the interpretation of the data by the FDA (for
example, the FDA continues to question the number of pregnancies
included in our results and they may adjudicate additional
pregnancies); our statements about the potential commercial
opportunity could be affected by potential labeling restrictions,
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. 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.
SOURCE: Agile Therapeutics, Inc.
Investor Relations Contact: Mary Coleman Agile
Therapeutics 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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