Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a
forward-thinking women’s healthcare company, today announced that
the U.S. Food and Drug Administration (FDA) has approved Twirla®
(levonorgestrel and ethinyl estradiol) transdermal system.
INDICATION AND USAGE
TWIRLA is 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.
Limitations of Use
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.
Please see Important Safety Information for TWIRLA, including
BOXED WARNING on Cigarette Smoking and Serious Cardiovascular
Events and Contraindication in Women with a BMI > 30 kg/m2,
below in “About Twirla.”
“Twirla is an important addition to available hormonal
contraceptive methods, allowing prescribers to now offer
appropriate U.S. women a weekly transdermal option that delivers
estrogen levels in line with labeled doses of many commonly
prescribed oral contraceptives,” said Dr. David Portman, a primary
investigator on the SECURE clinical trial. “I’m pleased that Agile
conducted a comprehensive study in a diverse population providing
important data to prescribers and to women seeking
contraception. It is vital to expand the full range of
contraceptive methods and inform the choices that fit an
individual’s family planning needs and lifestyle. I am
excited healthcare providers can now include Twirla among available
contraception options.”
Twirla is designed for weekly application to deliver a 30 mcg
daily dose of ethinyl estradiol, a type of estrogen, along with a
120 mcg daily dose of levonorgestrel, a well-known progestin with a
long history in the category. The newly approved patch can be
worn on the abdomen, buttock, or upper torso (excluding the
breasts).
“The FDA’s approval of Twirla will enable us to deliver on our
short-term goal of establishing Agile in the contraceptive
prescription market and working towards our longer-term mission to
broaden our women’s health portfolio, including in areas of unmet
need. We are grateful to the clinical trial patients, researchers,
healthcare providers, and advocates, whose contributions helped us
secure the approval of a new transdermal contraceptive option that
may serve the contraceptive needs and preferences of many women,”
said Al Altomari, chairman and chief executive officer, Agile
Therapeutics. "We are proud to offer this new option and look
forward to bringing Twirla to women and their healthcare
providers.”
As part of Twirla’s approval, the FDA is requiring Agile to
conduct a long-term prospective, observational post-marketing study
comparing the risks for venous thromboembolism (VTE) and arterial
thromboembolism (ATE) in new users of Twirla to new users of other
combined hormonal contraceptives (CHC). The FDA’s requirement
for Twirla is similar to another post-marketing study requirement
for a recently approved CHC. The final study report for the
Twirla study is scheduled to be submitted to the FDA in November
2032, with interim safety data reporting to the FDA due in November
2026. Agile has also agreed to a post-marketing commitment
(PMC) study to assess the residual drug content and strength of
Twirla in a minimum of 25 women, which will analyze the Twirla
ethinyl estradiol and levonorgestrel content after the prescribed
wear and will monitor adhesion. The PMC is similar to residual drug
studies requested of patch developers in the FDA’s November 2019
draft guidance entitled Transdermal and Topical Delivery Systems –
Product Development and Quality Considerations. The Company
plans to begin designing the post-approval studies and evaluating
related costs during the first half of 2020.
With the approval of Twirla, Agile will accelerate its
commercial activities. In the first quarter of 2020, Agile
plans to initiate work with managed care and patient payors to gain
market access for Twirla. Beginning in the second quarter of
2020, the Company plans to hire and train an initial sales team. In
parallel with these activities, Agile plans to complete the
validation of its commercial manufacturing process and expects to
ship initial product to wholesalers in the fourth quarter of 2020.
The Company believes that the potential new CHC users who have a
BMI <30 kg/m2 represent a significant population of women.
Based on the Company’s market research, analysis of the current and
expected future U.S. contraceptive market, and review of other
product launches in the category, the Company estimates that Twirla
can potentially achieve a peak market share of 5-8%. As the
Company prepares for the commercialization of Twirla, it will
continue to analyze the contraceptive market and update its market
research as it evaluates the commercial opportunity for Twirla.
About Twirla
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30
KG/M2 |
Cigarette Smoking and Serious Cardiovascular
EventsCigarette smoking increases the risk of
serious cardiovascular events from combined hormonal contraceptive
(CHC) use. This risk increases with age, particularly in women over
35 years of age, and with the number of cigarettes smoked. For this
reason, CHCs, including TWIRLA, are contraindicated in women who
are over 35 years of age and smoke.
Contraindicated in Women with a BMI ≥ 30
kg/m2TWIRLA 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 effectiveness and may have a higher risk
for venous thromboembolism events (VTEs). |
CONTRAINDICATIONS
TWIRLA is contraindicated and should not be used in women with a
high risk of arterial or venous thrombotic disease, including women
with a BMI ≥ 30 kg/m2; have headaches with focal neurological
symptoms, migraine with aura, women over 35 years of age with any
migraine headache; liver tumors, acute viral hepatitis, or severe
(decompensated) cirrhosis, or liver disease; undiagnosed abnormal
uterine bleeding; pregnancy; current or history of breast cancer or
other estrogen- or progestin-sensitive cancer; hypersensitivity to
any components of TWIRLA; and use of Hepatitis C drug combinations
containing ombitasvir/paraparesis/ritonavir with or without
dasabuvir.
WARNINGS AND PRECAUTIONS
- Thromboembolic Disorders and Other Vascular
Conditions- Women are at increased risk for a venous
thromboembolic event (VTE) when using TWIRLA
- Stop TWIRLA if an arterial or venous thrombotic/thromboembolic
event occurs
- Stop TWIRLA if there is unexplained loss of vision, proptosis,
diplopia, papilledema, or retinal vascular lesions. Evaluate for
retinal vein thrombosis immediately
- Discontinue TWIRLA during prolonged immobilization and, if
feasible, stop TWIRLA at least 4 weeks before and through 2 weeks
after major surgery
- Start TWIRLA no earlier than four weeks after delivery in women
who are not breast-feeding
- Before starting TWIRLA, evaluate any past medical history or
family history of thromboembolism or thromboembolic disorders and
consider whether history suggests inherited or acquired
hypercoagulopathy
Arterial Events- CHCs increase the
risk of cardiovascular events and cerebrovascular events, such as
myocardial infarction and stroke, particularly among older women
(> 35 years of age), smokers, and women with hypertension,
dyslipidemia, diabetes, or obesity.
- Liver Disease- Discontinue TWIRLA if jaundice
develops
- Risk of Liver Enzyme Elevations with Concomitant
Hepatitis C Treatment- Discontinue TWIRLA prior to
starting therapy with the combination drug regimen
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
TWIRLA can be restarted approximately 2 weeks following completion
of treatment with the Hepatitis C combination drug regimen.
- Hypertension- Monitor blood pressure at
routine visits and stop TWIRLA if blood pressure rises
significantly. An increase in blood pressure has been reported in
women using CHCs, and this increase is more likely in older women
with extended duration of use.
- Gallbladder Disease- Studies suggest CHCs
increase risk of developing gallbladder disease and may also worsen
existing gallbladder disease.
- Adverse Carbohydrate and Lipid Metabolic
Effects-
- TWIRLA may decrease glucose tolerance. Carefully monitor
prediabetic and diabetic women who are using TWIRLA.
- Consider alternative contraception for women with uncontrolled
dyslipidemia. TWIRLA may cause adverse lipid changes. Women with
hypertriglyceridemia, or a family history thereof, may have an
increase in serum triglyceride concentrations when using TWIRLA,
which may increase the risk of pancreatitis.
- Headache- If a woman using TWIRLA develops new
headaches that are recurrent, persistent, or severe, evaluate the
cause and discontinue TWIRLA if indicated. Consider discontinuation
of TWIRLA if there is any increased frequency or severity of
migraines during CHC use (which may be prodromal of a
cerebrovascular event).
- Bleeding Irregularities and Amenorrhea- Women
using TWIRLA may experience unscheduled bleeding, especially during
the first three months of use, or experience absence of scheduled
bleeding. If bleeding persists or occurs after previously regular
cycles on TWIRLA, or if scheduled bleeding does not occur, evaluate
for causes such as pregnancy or, in the case of unscheduled
bleeding, malignancy.
- Other Warnings and Precautions- Other warnings
and precautions include, depression, cervical cancer, increased
serum concentrations of binding globulins, hereditary angioedema,
and chloasma.
ADVERSE REACTIONSThe following serious adverse
reactions occurred in <1% of women who received TWIRLA:
cholelithiasis, cholecystitis, major depression, suicidal ideation,
appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A
total of four VTEs in TWIRLA-treated patients were identified in
the Phase 3 clinical trial. The most common adverse reactions (≥2%)
in clinical trials for TWIRLA are application site disorders,
nausea, headache, dysmenorrhea, and increased weight.
Patients should be counseled that TWIRLA does not protect
against HIV infection (AIDS) and other sexually transmitted
infections (STIs).
DRUG INTERACTIONSDrugs or herbal products that
induce certain enzymes, including CYP3A4, may decrease the
effectiveness of TWIRLA or increase breakthrough bleeding.
Counsel patients to use a back-up or alternative method of
contraception when enzyme inducers are used with TWIRLA.
INDICATIONS AND USAGE TWIRLA is 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. Limitations of Use: Consider TWIRLA’s reduced
effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before
prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥
30 kg/m2.
This is not a comprehensive list of safety information
related to TWIRLA. Please See Full
Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, call
1-855-888-2467 or report via the FDA MedWatch Program at
www.fda.gov/medwatch or 1-800-FDA-1088.
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 Linked In and Twitter: @AgileTher.
Forward-Looking Statement
Certain 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 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. 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, our
ability along with our third-party manufacturer, Corium, to
complete successfully the scale-up of the commercial manufacturing
process for Twirla, including the qualification and validation of
equipment related to the expansion of Corium's manufacturing
facility, the performance and financial condition of Corium or any
of the suppliers to our third-party manufacturer, the ability of
Corium to produce commercial supply in quantities and quality
sufficient to satisfy market demand for Twirla, our ability to
successfully commercialize Twirla, the successful development of
our sales and marketing capabilities, the accuracy of our estimates
of the potential market for 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.
SOURCE: Agile Therapeutics, Inc.
Contact: Investor Relations -- 609-683-1880
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