Agile Therapeutics Announces Findings of First-Year Post-Marketing Pharmacovigilance in ACOG Poster Presentation
06 5월 2022 - 6:01AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today publicly released the findings of its first year of
post-marketing pharmacovigilance safety surveillance for
Twirla
® (levonorgestrel and ethinyl estradiol)
transdermal system (LNG/EE TDS).
The contraceptive transdermal delivery system was approved by
the U.S. Food and Drug Administration (“FDA”) in February 2020 as a
method of contraception for use in women of reproductive potential
with a body mass index (BMI) < 30 kg/m2. Approval of LNG/EE TDS
was based on the SECURE study, which demonstrated safety in a large
diverse group of women in a clinical trial setting. The current
assessment provides an update of LNG/EE TDS safety based on
real-world post-marketing adverse event reporting.
Prescriptions for LNG/EE TDS were dispensed during this post
marketing period – December 2020 through December 2021 – with
additional patches dispensed as samples (for a total of about
11,000 women-years). No venous thromboembolic events (VTEs) were
reported, and two serious adverse events (SAEs) were reported,
findings which are consistent with the safety profile reported in
the SECURE study.
“These data from real-world use among a diverse US population
further support the Twirla safety and tolerability profile
established in the SECURE clinical trial,” said Paul Korner, MD,
MBA, Chief Medical Officer of Agile Therapeutics.
In addition to the safety findings, reports of TDS adhesion
issues were rare, and only 14 individuals received a replacement
patch over the 12-month period.
“As an investigator and clinician, it is encouraging to see that
Twirla’s safety and tolerability profile over the first year of
real-world use is consistent with the phase 3 SECURE trial results.
This level of data transparency and commitment to providing
clinicians with information can further enable them to make
informed decisions together with their patients,” said Robin Kroll,
MD, FACOG, SECURE Trial Investigator.
The poster, entitled Postmarketing Safety of a
Levonorgestrel/Ethinyl Estradiol Contraceptive Transdermal Delivery
System, was 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 and will be
available to meeting attendees in person, through the ACOG website
at https://www.acog.org, and the ACPG’s journal's website,
greenjournal.org beginning May 5, 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.
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 profile 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
market availability of Twirla and the consistency of Twirla’s
safety profile over time. 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 continued uptake of
Twirla in a broader patient population, 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
mriley@agiletherapeutics.com
Agile Therapeutics (NASDAQ:AGRX)
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