TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s
healthcare company, today announced the schedule of two oral
presentations and five posters that will be presented at the 2019
Annual Meeting of the North American Menopause Society (NAMS) being
held on September 25-28, 2019, related to IMVEXXY® (estradiol
vaginal inserts) and BIJUVA® (estradiol and progesterone
capsules).
“We are excited to report results from the REPLENISH Phase 3
trial for BIJUVA that show improvements in several sleep
parameters, including sleep disturbances, in menopausal women with
moderate to severe vasomotor symptoms taking BIJUVA as compared to
placebo. In addition, we will present data for BIJUVA showing a
consistency of effect for improvements in the frequency and
severity of vasomotor symptoms in different subpopulations,
regardless of age or body mass index,” said TherapeuticsMD Chief
Medical Officer Sebastian Mirkin, M.D.
Additionally, two oral presentations will review the growth of
the vulvar vaginal atrophy (VVA) market and patient acceptability
data, including patient satisfaction and preference, for
IMVEXXY.
The posters and presentations will be made available on the
Investors & Media section of the company’s website at
www.therapeuticsmd.com.
Oral Presentations
Date: September 27, 2019 Time: 4:15 - 4:30 pm
Title: Growth of the Vulvar Vaginal Atrophy (VVA) Therapy
Market
Date: September 27, 2019 Time: 4:30 - 4:45 pm
Title: Postmenopausal Women Using a Softgel Estradiol Vaginal
Insert to Treat Moderate-to-Severe Dyspareunia were Satisfied with
it and Preferred it over a Previous Therapy
Posters
Date: September 25, 2019 Time: 6:00 - 7:00 pm
Title: Uterine Bleeding Rates with Hormone Therapies in
Menopausal Women with Vasomotor Symptoms (Poster P-55)
Title: Baseline Estradiol Levels in Postmenopausal Women (Poster
P-11)
Title: Nonsmokers May Benefit from Lower Doses of an Oral
17β-Estradiol/Progesterone Capsule — Data from the REPLENISH Trial
(Poster P-12)
Title: Oral 17β-Estradiol/Progesterone (E2/P4) Improved Sleep
Outcomes in the REPLENISH Trial (Poster P-31)
Title: E2/P4 Capsules Effectively Treat Vasomotor Symptoms
Irrespective of Age and BMI (Poster P-6)
Please see the Full Prescribing Information, including
indication and Boxed WARNING, for IMVEXXY and BIJUVA as
follows:
- IMVEXXY (estradiol vaginal inserts) at
https://imvexxy.com/pi.pdf
- BIJUVA (estradiol and progesterone capsules) at
https://www.bijuva.com/pi.pdf
INDICATION
IMVEXXY (estradiol vaginal inserts) is an estrogen indicated for
the treatment of moderate-to- severe dyspareunia, a symptom of
vulvar and vaginal atrophy, due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed
warning.
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 Women’s Health Initiative (WHI) estrogen-alone substudy
reported increased risks of stroke and deep vein thrombosis
(DVT)
- The WHI Memory Study (WHIMS) estrogen-alone ancillary study
of WHI reported an increased risk of probable dementia in
postmenopausal women 65 years of age and older
Estrogen Plus Progestin
Therapy
- Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased
risks of stroke, DVT, pulmonary embolism (PE) and myocardial
infarction (MI)
- The WHI estrogen plus progestin substudy reported increased
risks of invasive breast cancer
- The WHIMS estrogen plus progestin ancillary study of WHI
reported an increased risk of probable dementia in postmenopausal
women 65 years of age and older
CONTRAINDICATIONS
- IMVEXXY is contraindicated in women with any of the following
conditions: undiagnosed abnormal genital bleeding; known,
suspected, or history of breast cancer; known or suspected
estrogen-dependent neoplasia; active DVT, PE, or history of these
conditions; active arterial thromboembolic disease or a history of
these conditions; known anaphylactic reaction or angioedema to
IMVEXXY; known liver impairment or disease; known protein C,
protein S, or antithrombin deficiency, or other known thrombophilic
disorders.
WARNINGS AND PRECAUTIONS
- IMVEXXY is intended only for vaginal administration. Systemic
absorption may occur with the use of IMVEXXY.
- The use of estrogen-alone and estrogen plus progestin therapy
has been reported to result in an increase in abnormal mammograms
requiring further evaluation.
- 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.
- Other warnings include: gallbladder disease; severe
hypercalcemia, loss of vision, severe hypertriglyceridemia or
cholestatic jaundice.
- Estrogen therapy may cause an exacerbation of asthma, diabetes
mellitus, epilepsy, migraine, porphyria, systemic lupus
erythematosus, and hepatic hemangiomas and should be used with
caution in women with these conditions.
- Women on thyroid replacement therapy should have their thyroid
function monitored.
ADVERSE REACTIONS
- The most common adverse reaction with IMVEXXY (incidence ≥ 3
percent) and greater than placebo was headache.
Please note that this information is not comprehensive.
Please see/click here for the Full Prescribing Information,
including the Boxed Warning.
INDICATION
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
- Estrogenplus 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.
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 ability of the company’s licensees to commercialize and
distribute the company’s products; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190924005148/en/
Investor Contact Nichol Ochsner, Vice President Investor
Relations 561-961-1900, ext. 2088 Nochsner@TherapeuticsMD.com
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