Agile Therapeutics Announces Peer-Reviewed Publication of Phase 3 SECURE Study Results for Twirla® (levonorgestrel and ethin...
November 30 2020 - 9:11AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today announced that Contraception, an international,
peer-reviewed, reproductive health journal, published the primary
safety, efficacy, and tolerability results from the Phase 3 SECURE
study evaluating Twirla® (levonorgestrel and ethinyl estradiol)
transdermal system. The results have been published online in
Contraception (https://bit.ly/SECUREStudy) and will also appear in
a future print edition of the journal.
“We at Agile are proud to have the primary data
from the SECURE trial published in this well-respected journal,”
said Paul Korner, MD, MBA, Chief Medical Officer for Agile
Therapeutics. “Twirla represents a new and important contraceptive
option for women, and we hope the publication of these Phase 3
results ensures that healthcare providers have the most relevant
and comprehensive information on the product ahead of the
commercial launch. We want to once again thank all the women and
researchers who were involved in this pivotal study.”
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 2,032 healthy women,
aged 18 years and over, at 102 investigational sites across the
United States. Based on the results of this study, Twirla was
approved by the U.S. Food and Drug Administration (FDA) on February
14, 2020 for the prevention of pregnancy in women with a BMI <
30 kg/m2 for whom a combined hormonal contraceptive is
appropriate.
“The study was unique in its rigorous design and
did not have restrictions on body weight or BMI, which resulted in
enrollment of a diverse and demographically representative
population of U.S. women,” said Anita Nelson, MD, Lead Author and
Primary Investigator in the SECURE study. “The publication
communicates important information to Health Care Providers which
affords them the opportunity to engage in a meaningful shared
decision-making process with 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 to prevent pregnancy. 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 designed to be applied once weekly for three
weeks, followed by a week without a patch.
About Agile Therapeutics,
Inc.Agile Therapeutics is a 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
initial product, Twirla®, (levonorgestrel and ethinyl estradiol)
transdermal system is a non-daily prescription contraceptive.
Twirla uses 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.
Contact: Matt RileyHead of Investor
Relations & Corporate
Communicationsmriley@agiletherapeutics.com
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