-BIJUVA is the only FDA-approved Therapy
Combining Bio-identical Estradiol and Progesterone for Moderate to
Severe Vasomotor Symptoms due to Menopause in a Single Capsule-
-Company to Hold Investor Day in New York on
Monday, June 10, 2019-
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, today announced the commercial
availability of BIJUVATM (estradiol and progesterone capsules, 1
mg/100 mg) in the United States. BIJUVA is the first and only
FDA-approved bio-identical hormone therapy combination of estradiol
and progesterone in a single, oral daily 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. BIJUVA
offers a proven balance of bio-identical estradiol to reduce
moderate to severe hot flashes combined with bio-identical
progesterone to reduce risks to the endometrium. Please see
Important Safety Information, including Boxed Warning, for BIJUVA
below.
Bio-identical refers to the estradiol and progesterone that are
structurally identical to the hormones naturally circulating in a
woman’s body.* The commercial availability of BIJUVA fills an unmet
need by offering an FDA-approved bio-identical alternative to
marketed synthetic hormone combinations and the combined use of
separate estrogen and progesterone products.
“We are excited to offer women, healthcare providers and
pharmacists an answer to their desire for bio-identical hormone
therapy,” said Dr. Brian Bernick, Co-founder and Director of
TherapeuticsMD. “TherapeuticsMD is proud to offer BIJUVA as an
important new option to help manage the moderate to severe
vasomotor symptoms experienced by up to 80% of menopausal
women.”
As of April 19, 2019, three of the top ten commercial payers –
Express Scripts, Anthem and Aetna – will be adjudicating BIJUVA in
the commercial health insurance channel for the majority of their
formulary designs.
“The momentum we have seen early on with the payer community is
encouraging and indicates recognition of the need for an
FDA-approved combination bio-identical option,” said Dawn Halkuff,
Chief Commercial Officer of TherapeuticsMD. “I am proud to work for
a company committed to advancing women’s health with new treatments
for women and their healthcare providers.”
TherapeuticsMD plans to hold an Investor Day in New York on
Monday, June 10, 2019 to highlight its commercial strategy for its
product portfolio, including BIJUVA.
*The relevance of risks associated with the use of synthetic
hormones compared to bio-identical hormones is not known, but
cannot be excluded.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women that
usually occurs at an average onset of 51 years of age.1 According
to the United States Census Bureau, approximately 43 million women
in the U.S. are of menopausal age (45-64 years) and women will
spend greater than a third of their life in menopause with its
associated morbidities.2
As the ovaries stop producing hormones, levels of circulating
estrogen decrease, often causing vasomotor symptoms (VMS) (commonly
known as hot flashes or flushes), as well as sleep and mood
disturbances and genitourinary problems. Hot flashes (including
night sweats) are the most common symptoms, occurring in up to 80
percent of women, and can be debilitating and last years after
menopause.3 Despite living with these troublesome symptoms, many
women do not seek treatment.
About BIJUVA
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. There are an estimated 16 to 22 million total
prescriptions of the FDA-approved separate bio-identical estradiol
and progesterone and compounded bio-identical estrogen and
progesterone products filled annually in the US.4
BIJUVA IMPORTANT SAFETY INFORMATION
BIJUVA is a combination of an estrogen and progesterone
indicated in a woman with a uterus for the treatment of moderate to
severe vasomotor symptoms due to menopause.
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 & 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, for BIJUVA at
https://www.bijuva.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 agreement; 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.
References
1 NAMS “Overview of Menopause” 2010. 2 US Census Bureau. Age
and Sex Composition: 2010. 2011 May. Report No.: C2010BR-03. 3
Woods NF, Mitchell ES. Symptoms during the perimenopause:
prevalence, severity, trajectory, and signi-ficance in women’s
lives. Am J Med. 2005;118(suppl 12B):14–24. 4 Symphony Health
Solutions PHAST Data powered by IDV; 12 months as of December 31,
2018 and Composite of Fisher, J. QuintilesIMS, White Paper: A
Profile of the US Compounding Pharmacy Market, internal surveying
of compounding pharmacies.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190417005218/en/
Investor ContactNichol
OchsnerVice President, Investor Relations561-961-1900, ext.
2088Nochsner@TherapeuticsMD.com
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