Agile Therapeutics® Announces Poster Presentation at the 2022 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG)
07 4월 2022 - 8:30PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today announced that data from the company’s first-year of
postmarketing pharmacovigilance safety surveillance for Twirla®
(levonorgestrel and ethinyl estradiol) transdermal system, will be
presented at the 2022 American College of Obstetricians and
Gynecologists (ACOG) Annual Clinical and Scientific Meeting.
“Patient safety is a primary focus for Agile Therapeutics. We
are encouraged by Twirla’s first-year post-marketing
pharmacovigilance data and thought it important to share this
information with the healthcare community,” said Paul Korner, MD,
MBA, Chief Medical Officer of Agile Therapeutics.
The poster, entitled Postmarketing Safety of a
Levonorgestrel/Ethinyl Estradiol Contraceptive Transdermal Delivery
System, authored by Robin Kroll, MD, Andrew M. Kaunitz, MD, FACOG,
Beata Teixeira de Mattos, Joseph A. Chiodo III, PharmD, Michelle L.
Previtera, PhD, and Paul Korner, MD, MBA,, will be presented by
Robin Kroll, MD and will be available to meeting attendees in
person and through the ACOG website at https://www.acog.org,
beginning May 6, 2022.
About
Twirla®Twirla® (levonorgestrel and
ethinyl estradiol) transdermal system is a once-weekly combined
hormonal contraceptive (CHC) patch that contains the active
ingredients levonorgestrel (LNG), a type of progestin, and ethinyl
estradiol (EE), a type of estrogen. Twirla is indicated for use as
a method of contraception by women of reproductive potential with a
body mass index (BMI) < 30 kg/m2 for whom a combined
hormonal contraceptive is appropriate. Healthcare providers (HCPs)
are encouraged to consider Twirla’s reduced efficacy in women with
a BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is
contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also
contraindicated in women over 35 years old who smoke. Cigarette
smoking increases the risk of serious cardiovascular events from
CHC use. Twirla is designed to be applied once weekly for three
weeks, followed by a week without a patch.
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. Twirla and 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. Twirla® and our pipeline products are based on
our proprietary transdermal patch technology, called Skinfusion®,
which is designed to allow drug delivery through the skin. 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”, within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, related to our regulatory submissions and
safety reporting for Twirla. We may, in some cases use terms such
as “predicts,” “believes,” “potential,” “continue,” “anticipates,”
“estimates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “likely,” “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, including statements regarding the
safety profile of Twirla. 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. These forward-looking statements are subject to
risks and uncertainties including risks related to our ability
maintain regulatory approval of Twirla, the possibility that Twirla
could develop unexpected safety, efficacy or quality concerns, our
ability to successfully commercialize Twirla, regulatory and
legislative developments in the United States and foreign
countries, our ability to obtain and maintain intellectual property
protection for Twirla, our strategy, business plans and focus, and
the other risks set forth in our filings with the U.S.
Securities and Exchange Commission, including our Annual Report on
Form 10-K and our Quarterly Reports on Form 10-Q. For all
these reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. 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:
Matt Riley
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com
Agile Therapeutics (NASDAQ:AGRX)
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