Agile Therapeutics Announces Presentation of Safety and Efficacy Data of Twirla® (Levonorgestrel and Ethinyl Estradiol) Tran...
April 30 2021 - 11:01AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today announced that a post hoc analysis of the Phase
3 SECURE Trial evaluating the safety and efficacy of Twirla®
(levonorgestrel and ethinyl estradiol) transdermal system in women
with BMI < 25 kg/m2 and women with BMI 25-30 kg/m2 will be
presented at the American College of Obstetricians and
Gynecologists (ACOG) Annual Clinical and Scientific Meeting from
April 30 – May 2.
Twirla was approved based on the Phase 3 SECURE Trial, a United
States, multicenter, single-arm, open-label, 13-cycle trial that
evaluated the efficacy, safety and tolerability of Twirla in 2,032
healthy women. Twirla is a combination of levonorgestrel and
ethinyl estradiol indicated as a method of contraception for use in
women of reproductive potential with a BMI < 30 kg/m2 for whom a
combined hormonal contraceptive is appropriate. The U.S. package
insert also includes a Limitation of Use statement guiding
prescribers to consider Twirla’s reduced effectiveness in women
with a BMI ≥ 25 to < 30 kg/m2 before prescribing. Twirla is
contraindicated in women with a BMI ≥ 30 kg/m2. This post hoc
analysis of SECURE assessed the efficacy, safety and tolerability
of Twirla in women with BMI < 25 kg/m2 and BMI 25-30 kg/m2. When
compared to women with BMI < 25 kg/m2, Twirla demonstrated lower
but acceptable efficacy while maintaining similar safety and
tolerability in women with BMI 25-30 kg/m2.
“The results of this post hoc analysis help to inform providers
counseling women that fall within BMI 25-30 kg/m2 who may be
considering a non-oral, noninvasive contraception option,”
said Anita Nelson, MD, Lead Author and Primary Investigator in
the SECURE study. “These data support the safety and
tolerability of Twirla in women within BMI 25-30 kg/m2 as well as
those with BMI < 25 kg/m2.”
“At Agile, we are committed to addressing the needs of women
through our products and the generation of new analyses that better
enable healthcare providers to counsel their patients. This is
directly reflective of the population enrolled in our SECURE
trial,” said Paul Korner, MD, MBA, Chief Medical Officer
for Agile Therapeutics. “This post hoc analysis provides
additional information about Twirla relative to the BMI categories
for which Twirla is indicated that could facilitate data-driven
conversations between healthcare providers and their patients.”
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 over 35 years old who smoke. Cigarette
smoking increases the risk of serious cardiovascular events from
CHC use. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2.
Compared to women with a lower BMI, women with a BMI ≥ 30 kg/m2 had
reduced efficacy and may have a higher risk for venous
thromboembolic events. 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-looking women's healthcare company
dedicated to fulfilling the unmet health needs of today’s
women. Our product and 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 initial product, Twirla®, (levonorgestrel and
ethinyl estradiol), a transdermal system, 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. 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.
Contact:Matt RileyHead of Investor Relations
& Corporate Communicationsmriley@agiletherapeutics.com
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