Poster Will Present BIJUVA Phase 3 REPLENISH
Data About Improvements in the Frequency and Severity of Hot
Flashes in Postmenopausal Women
Oral Presentation and Posters Will Present
ANNOVERA Phase 3 Data About User Satisfaction and Safety
Profile
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, today announced the schedule of
presentations on BIJUVATM (estradiol and progesterone capsules, 1
mg/100 mg) and ANNOVERA™ (segesterone acetate/ethinyl estradiol
vaginal system) at the American College of Obstetricians and
Gynecologists (ACOG) 2019 Annual Meeting in Nashville on May 3-6,
2019.
“Data from the REPLENISH Phase 3 trial for BIJUVA showed
significant improvement in the frequency and severity of vasomotor
symptoms, regardless of the number and severity of hot flushes at
baseline. This is important because it further supports the
robustness of the BIJUVA data, as it is the only FDA-approved,
bio-identical combination hormone therapy,” said TherapeuticsMD
Chief Medical Officer Sebastian Mirkin, M.D.
BIJUVA is the first and only FDA-approved, bio-identical hormone
therapy combination of estradiol and progesterone in a single, oral
capsule for the treatment of moderate-to-severe vasomotor symptoms
(commonly known as hot flashes or flushes) due to menopause in
women with a uterus. Please see the Important Safety Information,
including Boxed Warning, for BIJUVA below.
Data on ANNOVERA, a contraceptive vaginal system that contains a
novel progestin, segesterone acetate, demonstrated potent
antiovulatory effects in preventing pregnancy.
“The data in these presentations show that ANNOVERA is a highly
effective contraceptive option that lasts for an entire year and
can be self-inserted and removed each cycle. Data show a high level
of user satisfaction, which is significant as all other long-acting
contraceptive products require a procedure for both insertion and
removal,” said Dr. Brian Bernick, Co-founder and Director of
TherapeuticsMD. “These presentations also show that women who used
ANNOVERA for up to 13 cycles did not experience any unexpected
safety findings, and only 1.7% of women discontinued due to
irregular bleeding.”
ANNOVERA is the first long-term prescription birth control that
is patient-controlled, procedure-free and reversible. This small,
soft, flexible ring prevents ovulation for an entire year (13
cycles) and can be inserted and removed by a woman at her
discretion in repeated four-week cycles (remaining in place
continuously for three weeks followed by removal for one week).
Please see the Important Safety Information, including Boxed
Warning, for ANNOVERA below.
The posters and oral presentations will be made available on the
Investors & Media section of the company’s website at
www.therapeuticsmd.com.
Poster
Presentations
Date: Saturday, May 4
Time and Location: 11:30 – 12:30
PM, ePoster Session J
Title: Effects of TX-001HR in Women
with <50 Moderate-to-Severe Hot Flushes per Week
Authors: R Kagan, G Constantine, S
Graham, B Bernick, S Mirkin
Date: Saturday, May 4
Time and Location: 3:00 PM – 4:00
PM, ePoster Session M
Title: Predictors of Frequency and
Severity of Vasomotor Symptoms: Results from the REPLENISH
Trial
Authors: D Bitner, G Constantine, S
Graham, B Bernick, S Mirkin
Date: Saturday, May 4
Time and Location: 3:00 PM – 4:00
PM, ePoster Session M
Title: Bleeding Patterns with a
1-Year, Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal
System
Authors: AL Nelson, CS Vieira, I
Fraser, AE Burke, ML Gilliam, V Brache
Date: Saturday, May 4
Time and Location: 3:00 – 4:00 PM,
ePoster Session M
Title: Endometrial Safety with a
1-Year Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal
System
Authors: DF Archer, KT Barnhart, MD
Creinin, JT Jensen, MA Thomas, DL Blithe
Date: Saturday, May 4
Time and Location: 3:00 PM – 4:00
PM, ePoster Session M
Title: Segesterone Acetate/Ethinyl
Estradiol 1-Year Contraceptive Vaginal System Safety Evaluation
Authors: MA Thomas, K
Gemzell-Danielsson, MD Creinin, KT Barnhart, MJ Miranda, R
Sitruk-Ware
Oral
Presentations
Date: Saturday, May 4
Time and Location: 7:40 AM – 7:50
AM, Oral Presentation N
Title: Men’s Perceptions and
Attitudes Towards Menopause and Their Role in Their Partner’s
Menopausal Transition
Authors: SJ Parish, SS Faubion, M
Weinberg, B Bernick, S Mirkin
Date: Saturday, May 4
Time and Location: 5:20 PM – 5:30
PM, Oral Presentation O
Title: Efficacy of the 1-Year
Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal
System
Authors: C Westhoff, P Darney, JT
Jensen, L Bahamondes, D Apter, RB Merkatz
BIJUVA IMPORTANT SAFETY INFORMATION
BIJUVA™ is a combination of estradiol and progesterone indicated
in a woman with a uterus for the treatment of moderate to severe
vasomotor symptoms due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER,
ENDOMETRIAL CANCER, and PROBABLE DEMENTIA See full
prescribing information for complete boxed warning.
Estrogen Plus
Progestin Therapy
- Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular disease or dementia
- The Women’s Health Initiative (WHI) estrogen plus progestin
substudy reported increased risks of stroke, deep vein thrombosis
(DVT), pulmonary embolism (PE), and myocardial infarction
(MI)
- The WHI estrogen plus progestin substudy reported increased
risks of invasive breast cancer
- The WHI Memory Study (WHIMS) estrogen plus progestin
ancillary study of WHI reported an increased risk of probable
dementia in postmenopausal women 65 years of age or older
Estrogen-Alone
Therapy
- There is an increased risk of endometrial cancer in a woman
with a uterus who uses unopposed estrogens
- Estrogen-alone therapy should not be used for the prevention
of cardiovascular disease or dementia
- The WHI estrogen-alone substudy reported increased risks of
stroke and DVT
- The WHIMS estrogen-alone ancillary study of WHI reported an
increased risk of probable dementia in postmenopausal women 65
years of age or older
CONTRAINDICATIONS
BIJUVA is contraindicated in women with any of the following
conditions: undiagnosed abnormal genital bleeding; known,
suspected, or history of cancer of the breast; known or suspected
estrogen-dependent neoplasia; active DVT, PE, or history of these
conditions; active arterial thromboembolic disease (for example,
stroke, MI), or a history of these conditions; known anaphylactic
reaction, angioedema, or hypersensitivity to BIJUVA or any of its
ingredients; known liver impairment or disease; known protein C,
protein S, or antithrombin deficiency, or other known thrombophilic
disorders.
WARNINGS AND PRECAUTIONS
- An increased risk of PE, DVT, stroke,
and MI has been reported with estrogen plus progestin therapy.
Should these occur or be suspected, therapy should be discontinued
immediately. Risk factors for arterial vascular disease and/or
venous thromboembolism (VTE) should be managed appropriately.
- The WHI substudy of daily estrogen plus
progestin after a mean follow-up of 5.6 years reported an increased
risk of invasive breast cancer. Observational studies have also
reported an increased risk of breast cancer for estrogen plus
progestin therapy after several years of use. The risk increased
with duration of use and appeared to return to baseline over about
5 years after stopping treatment (only the observational studies
have substantial data on risk after stopping). The use of estrogen
plus progestin therapy has been reported to result in an increase
in abnormal mammograms requiring further evaluation.
- Endometrial hyperplasia (a possible
precursor to endometrial cancer) has been reported to occur at a
rate of approximately less than one percent with BIJUVA. Clinical
surveillance of all women using estrogen plus progestin therapy is
important. Adequate diagnostic measures should be undertaken to
rule out malignancy in postmenopausal women with undiagnosed
persistent or recurring abnormal genital bleeding.
- The WHI estrogen plus progestin
substudy reported a statistically non-significant increased risk of
ovarian cancer. A meta-analysis of 17 prospective and 35
retrospective epidemiology studies found that women who used
hormonal therapy for menopausal symptoms had an increased risk for
ovarian cancer. The exact duration of hormone therapy use
associated with an increased risk of ovarian cancer, however, is
unknown.
- In the WHIMS ancillary studies of
postmenopausal women 65 to 79 years of age, there was an increased
risk of developing probable dementia in women receiving estrogen
plus progestin when compared to placebo. It is unknown whether
these findings apply to younger postmenopausal women.
- Estrogens increase the risk of
gallbladder disease.
- Discontinue estrogen if severe
hypercalcemia, loss of vision, severe hypertriglyceridemia, or
cholestatic jaundice occurs.
- Monitor thyroid function in women on
thyroid replacement hormone therapy.
ADVERSE REACTIONS
The most common adverse reactions (≥3%) for BIJUVA are breast
tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%),
vaginal discharge (3.4%) and pelvic pain (3.1%).
Please note that this information is not comprehensive.
Please see the Full Prescribing Information including BOXED WARNING
at www.BIJUVA.com.
ANNOVERA IMPORTANT SAFETY INFORMATION
ANNOVERA is a progestin/estrogen combination hormonal
contraceptive (CHC) indicated for use by females of reproductive
potential to prevent pregnancy. (Limitation of use: Not adequately
evaluated in females with a BMI of > 29 kg/m2).
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of cardiovascular events
from CHC use. This risk increases with age, particularly in females
over 35 years of age, and with the number of cigarettes smoked.
CHCs should not be used by females who are over 35 years of age
and smoke.
Due to increased risks of serious side effects, ANNOVERA should
not be used in females with certain medical conditions, including
females who have a high risk of arterial or venous thrombotic
diseases; who have or have had breast cancer or other estrogen- or
progestin-sensitive cancer; who have liver tumors, acute hepatitis,
severe cirrhosis, undiagnosed abnormal uterine bleeding, or
hypersensitivity to any ingredients in ANNOVERA; who use certain
Hepatitis C drug combinations; or who are pregnant or
breastfeeding.
Risks from use of a CHC, like ANNOVERA, particularly in females
with any condition listed above, include venous thrombotic events;
cardiovascular events and cerebrovascular events such as stroke and
myocardial infarction; liver disease; elevated liver enzymes with
concomitant Hepatitis C treatment; hypertension; carbohydrate and
lipid metabolic effects; headache; bleeding irregularities and
amenorrhea.
ANNOVERA does not protect against HIV-infection (AIDS) and other
sexually transmitted infections.
Please note that this information is not comprehensive.
Please see the Full Prescribing Information, including the Boxed
Warning, for ANNOVERA at
www.annovera.com/pi.pdf.
About TherapeuticsMD, Inc.
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 company’s ability to maintain or
increase sales of its products; the company’s ability to develop
and commercialize IMVEXXY®, ANNOVERA™, BIJUVA™ and its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company will be able to comply with the
covenants and conditions under its term loan facility; 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; 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 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. PDF copies of the
company’s historical press releases and financial tables can be
viewed and downloaded at its
website: www.therapeuticsmd.com/pressreleases.aspx.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190503005098/en/
Nichol OchsnerVice President, Investor Relations561-961-1900,
ext. 2088Nochsner@TherapeuticsMD.com
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