TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, announced today that the Company
submitted a supplemental New Drug Application (“sNDA”) for BIJUVA
(estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S.
Food and Drug Administration (“FDA”).
The Company expects to learn of the acceptance of the sNDA upon
receipt of the Filing Review Notification from the FDA,
approximately 74 days after submission. If accepted, the Company
expects that the review time under the Prescription Drug User Fee
Act (PDUFA) will be within ten months of receipt by the FDA,
approximately March 21, 2022.
“We are pleased to have identified a path forward for submission
to the FDA of our sNDA for low-dose BIJUVA. We believe low-dose
BIJUVA will be an important additional therapeutic option for
women, if approved, and we look forward to bringing it to market,”
said Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD.
BIJUVA is the only FDA-approved bio-identical hormone therapy
combination of estradiol and progesterone in a single, oral
capsule. It is taken once-daily for the treatment of moderate to
severe vasomotor symptoms (commonly known as hot flashes or
flushes) due to menopause in women with a uterus.
About BIJUVA
BIJUVA is a novel combination of bio-identical estradiol and
bio-identical progesterone in a once-daily oral softgel capsule.
BIJUVA is approved in the U.S. in a 1mg/100mg strength for the
treatment of moderate to severe vasomotor symptoms due to menopause
in women with a uterus.
INDICATION
BIJUVA (estradiol and progesterone) 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.
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 and 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 and 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.
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
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 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: whether the FDA will accept and approve the NDA
efficacy supplement for the lower dose of BIJUVA; 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 how the proceeds that may be
generated by any such divestiture will be utilized; 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 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/20210525005287/en/
Investor Contacts Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
In-Site Communications, Inc. Lisa M. Wilson 212-452-2793
lwilson@insitecony.com
Media Contact Kristen Landon
Vice President, Marketing and Corporate Communications 561-961-1900
Klandon@therapeuticsmd.com
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