TherapeuticsMD Announces Poster Presentation of ANNOVERA® Data at the American College of Obstetricians & Gynecologists 2021...
May 03 2021 - 7:00AM
Business Wire
-Poster included analyses of ANNOVERA Phase 3
menstrual bleeding profile data-
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s
healthcare company, today announced Phase 3 menstrual bleeding
profile data for ANNOVERA (segesterone acetate and ethinyl
estradiol vaginal system) was presented at the 2021 American
College of Obstetricians and Gynecologists (ACOG) Annual Clinical
and Scientific Meeting conducted virtually from April 30 to May 2,
2021.
“Menstrual bleeding patterns for women may change with
contraceptive use, and predictable bleeding (cycle control) is a
key factor that impacts women’s selection, adherence and
continuation of combined hormonal contraception. In clinical
studies, ANNOVERA showed predictable scheduled bleeding for most
women. An unpredictable bleeding profile is very important because
it is a common reason that women tend to switch among different
contraceptives,” said David F. Archer, MD at Eastern Virginia
Medical School.
Results were pooled from two identically designed, open-label
Phase 3 trials of ANNOVERA. Bleeding data were available from 2,070
women a total of 453,622 patient-days evaluated for bleeding. Based
on ANNOVERA use for up to 13 cycles, a daily average of 94.8% to
97.6% of women reported no unscheduled bleeding in each cycle. The
daily percentage of women presenting unscheduled bleeding (≤1.4%)
or spotting (≤3.6%) was consistently low throughout the 13 cycles
of ANNOVERA use. The median number of unscheduled bleeding/spotting
days remained stable across the 13 cycles of ANNOVERA use. Less
than 2% of women discontinued ANNOVERA due to bleeding-related
adverse events.
About ANNOVERA
ANNOVERA is the first and only FDA-approved long-lasting,
reversible contraceptive for women of reproductive age that is
patient-controlled and procedure-free. ANNOVERA was developed by
the global non-profit research organization, Population Council,
and has been licensed to TherapeuticsMD for the U.S. market.
IMPORTANT RISK INFORMATION
- Do not use ANNOVERA (segesterone acetate and ethinyl
estradiol vaginal system) if you smoke cigarettes and are over 35
years old. Smoking increases your risk of serious heart and blood
vessel (cardiovascular) side effects from hormonal birth control
methods, including death from heart attack, blood clots, or stroke.
This risk increases with age and the number of cigarettes you
smoke.
- ANNOVERA does not protect against HIV infection (AIDS) and
other sexually transmitted infections (STIs).
DO NOT USE ANNOVERA IF YOU
- have or have had a blood clot in your arms, legs, lungs, or
eyes.
- have had a stroke.
- have reduced blood flow to your brain (cerebrovascular
disease).
- have reduced blood flow or blockage in 1 or more of the
arteries that supply blood to your heart (coronary artery
disease).
- have had a heart attack.
- have heart rhythm or heart valve problems that increase your
risk of having blood clots, such as an infection of the inner
lining of the heart and heart valves or a type of irregular
heartbeat called atrial fibrillation.
- have a problem with your blood that makes it clot more than
normal.
- have high blood pressure that is not controlled with medicine
or have high blood pressure with blood vessel damage.
- have diabetes and are over 35 years old; have diabetes with
high blood pressure or problems with your kidneys, blood vessels,
eyes, or nerves; or have had diabetes for longer than 20
years.
- have headaches with changes in vision, numbness or weakness,
have migraine headaches with aura, or are over age 35 years old and
have any type of migraine headaches.
- have liver disease or liver tumors.
- have or have had breast cancer or any cancer that is sensitive
to the female hormones estrogen or progesterone.
- have unexplained vaginal bleeding.
- are allergic to segesterone acetate, ethinyl estradiol, or any
of the ingredients in ANNOVERA.
- take any Hepatitis C drug combination medicine containing
ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir.
WARNINGS
ANNOVERA can cause serious side effects, including: blood
clots; toxic shock syndrome (TSS); liver problems, including liver
tumors; high blood pressure; gallbladder problems; changes in the
sugar and fat (cholesterol and triglycerides) levels in your blood;
headache; irregular or unusual vaginal bleeding and spotting
between your menstrual periods; depression; possible cancer in your
cervix; swelling of your skin especially around your mouth, eyes,
and in your throat (angioedema); dark patches of skin on your
forehead, cheeks, upper lip, and chin (chloasma). Call your
healthcare provider or get emergency medical care right away if any
of these serious side effects occur.
The most common side effects of ANNOVERA include:
- headache, including migraine
- nausea/vomiting
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- diarrhea
- genital itching
USE
ANNOVERA is a ring-shaped vaginal system with hormones used by
females to prevent pregnancy.
ANNOVERA has not been adequately studied in females with a body
mass index >29 kg/m2.
The risk information provided here is not complete. To learn
more, review the ANNOVERA Patient Information and talk with your
healthcare provider or pharmacist. The FDA-approved product
labeling, including Patient Information, can be found at
annovera.com/pi.pdf.
You may report side effects to the FDA at
www.fda.gov/medwatch or by calling 1-800-FDA-1088.
You may also report side effects to TherapeuticsMD at
1-888-228-0150.
About TherapeuticsMD
TherapeuticsMD, Inc. is an innovative, leading healthcare
company, focused on developing and commercializing novel products
exclusively for women. Our products are designed to address the
unique changes and challenges women experience through the various
stages of their lives with a therapeutic focus in family planning,
reproductive health, and menopause management. The Company is
committed to advancing the health of women and championing
awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on
Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
Forward Looking Statements
This press release by TherapeuticsMD, Inc. may contain
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to TherapeuticsMD’s
objectives, plans and strategies as well as statements, other than
historical facts, that address activities, events or developments
that the company intends, expects, projects, believes or
anticipates will or may occur in the future. These statements are
often characterized by terminology such as "believes," "hopes,"
"may," "anticipates," "should," "intends," "plans," "will,"
"expects," "estimates," "projects," "positioned," "strategy" and
similar expressions and are based on assumptions and assessments
made in light of management’s experience and perception of
historical trends, current conditions, expected future developments
and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this
press release, and the company undertakes no duty to update or
revise any such statements, whether as a result of new information,
future events or otherwise. Forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties, many of which are outside of the company’s control.
Important factors that could cause actual results, developments and
business decisions to differ materially from forward-looking
statements are described in the sections titled "Risk Factors" in
the company’s filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, as well as reports on Form 8-K, and include
the following: the effects of the COVID-19 pandemic; the company’s
ability to maintain or increase sales of its products; the
company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®,
and BIJUVA® and obtain additional financing necessary therefor;
whether the company will be able to comply with the covenants and
conditions under its term loan facility; whether the company will
be able to successfully divest its vitaCare business and the
proceeds that may be generated by such divestiture; the potential
of adverse side effects or other safety risks that could adversely
affect the commercialization of the company’s current or future
approved products or preclude the approval of the company’s future
drug candidates; whether the FDA will approve the lower dose of
BIJUVA; the company’s ability to protect its intellectual property,
including with respect to the Paragraph IV notice letters the
company received regarding IMVEXXY and BIJUVA; the length, cost and
uncertain results of future clinical trials; the company’s reliance
on third parties to conduct its manufacturing, research and
development and clinical trials; the ability of the company’s
licensees to commercialize and distribute the company’s products;
the ability of the company’s marketing contractors to market
ANNOVERA; the availability of reimbursement from government
authorities and health insurance companies for the company’s
products; the impact of product liability lawsuits; the influence
of extensive and costly government regulation; the volatility of
the trading price of the company’s common stock and the
concentration of power in its stock ownership.
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version on businesswire.com: https://www.businesswire.com/news/home/20210503005190/en/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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