TherapeuticsMD Announces Submission of New Drug Application Prior Approval Efficacy Supplement to the U.S. Food & Drug Admini...
03 February 2020 - 10:30PM
Business Wire
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s
healthcare company, announced today that it submitted a New Drug
Application prior-approval efficacy supplement for BIJUVA 0.5
mg/100 mg (estradiol and progesterone) capsules to the U.S. Food
and Drug Administration (FDA) late January 2020.
The submission includes data from the Company’s Phase 3
Replenish Trial for BIJUVA, for which the Company announced results
in December 2016, together with additional information and
analyses. The Company expects to learn of the acceptance of the
efficacy supplement upon receipt of the Filing Review Notification
from the FDA, approximately 74 days after the submission of the NDA
efficacy supplement. If accepted for review by the FDA, the Company
expects that the NDA efficacy supplement will be reviewed under
current Prescription Drug User Fee Act timeline goals, within ten
months of receipt by the FDA.
The BIJUVA 1 mg/100 mg dose was approved by the FDA in October
2018 and launched commercially in April 2019. 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. It
is approved in the U.S. for the treatment of moderate to severe
vasomotor symptoms due to menopause in women with a uterus.
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
- 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 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, including the conditions
to draw additional tranches thereunder; 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 efficacy supplement
for the lower dose of 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
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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TherapeuticsMD Investors
Nichol Ochsner Vice President, Investor Relations 561-961-1900,
ext. 2088 Nochsner@TherapeuticsMD.com
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