- No Filing Review Issues Identified -
- PDUFA target action date of October 28, 2018-
BOCA RATON, Fla.--(BUSINESS WIRE)--Mar. 8, 2018--
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare
company, today announced the acceptance of the NDA for TX-001HR by the
U.S. Food and Drug Administration (FDA). TX-001HR is the company’s
investigational bio-identical hormone therapy combination of estradiol
and progesterone in a single, oral softgel for the treatment of
moderate-to-severe vasomotor symptoms due to menopause.
The FDA in its 74-day letter stated that the application is sufficiently
complete to permit a substantive review and that, at this time, the FDA
has not identified any potential review issues. The FDA noted that the
filing review is only a preliminary evaluation of the application and is
not indicative of deficiencies that may be identified during the FDA’s
review. The PDUFA target action date for the completion of the FDA's
review is October 28, 2018.
“The acceptance of the NDA for TX-001HR is another important milestone
for TherapeuticsMD and reaffirms the strength and commitment of our
organization,” said TherapeuticsMD CEO Robert G. Finizio. “If approved,
TX-001HR has the potential to be the first and only combination of
bio-identical estradiol and bio-identical progesterone in a single, oral
softgel to meet the needs of patients, physicians, and pharmacies as an
FDA-approved, third-party reimbursed treatment option for women
suffering from moderate-to-severe vasomotor symptoms due to menopause.”
The 505(b)(2) NDA submission for TX-001HR is supported by the complete
TX-001HR clinical program, including positive results of the phase 3
Replenish Trial, which evaluated the safety and efficacy of four doses
of TX-001HR (1 mg estradiol/100 mg progesterone, 0.5 mg estradiol/100 mg
progesterone, 0.5 mg estradiol/50 mg progesterone, 0.25 mg estradiol/50
mg progesterone) compared to placebo. The co-primary efficacy endpoints
in the Replenish Trial were the change from baseline in the number and
severity of hot flashes at weeks 4 and 12 as compared to placebo. The
primary safety endpoint was the incidence of endometrial hyperplasia
with up to 12 months of treatment. General safety was also evaluated.
Both the 1 mg estradiol/100 mg progesterone and the 0.5 mg estradiol/100
mg progesterone doses achieved statistically significant and clinically
meaningful results across the four co-primary efficacy endpoints. In
addition, the incidence rate of endometrial hyperplasia was 0% across
all doses with up to 12 months of treatment, meeting the primary safety
endpoint of less than 1% incidence of endometrial hyperplasia.
About TX-001HR
TX-001HR is the company’s investigational bio-identical hormone therapy
combination of estradiol and progesterone in a single, oral softgel for
the treatment of moderate-to-severe vasomotor symptoms due to menopause.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women with an average
onset of 51 years. According to the United States Census Bureau,
approximately 43 million women in the U.S. are of menopausal age (45-64
years).
As the ovaries stop producing hormones, levels of circulating estrogen
decrease, often causing vasomotor symptoms (VMS) such as night sweats,
hot flashes, and sleep disturbances. VMS affect as many as 60-80 percent
of all menopausal women.
Menopausal women can benefit from hormone therapy (HT), also known as
hormone replacement therapy (HRT), which is recognized by key medical
societies as the most effective treatment for relief of symptoms related
to menopause.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing products exclusively for women. With its
SYMBODA™ technology, TherapeuticsMD is developing advanced hormone
therapy pharmaceutical products to enable delivery of bio-identical
hormones through a variety of dosage forms and administration routes.
The Company’s late stage clinical pipeline includes two product
candidates that have completed phase 3 trials and are awaiting approval
by the FDA: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause.. The
Company also manufactures and distributes branded and generic
prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD®
brands.
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 resolve the deficiencies
identified by the FDA in the company’s new drug application for its
TX-004HR product candidate and the time frame associated with such
resolution; whether the FDA will approve the amended NDA for the
company’s TX-004HR product candidate and whether such approval will
occur by the PDUFA target action date; whether the FDA will approve the
NDA for the company’s TX-001HR product candidate and whether such
approval will occur by the PDUFA target action date; the company’s
ability to maintain or increase sales of its products; the company’s
ability to develop and commercialize its hormone therapy drug candidates
and obtain additional financing necessary therefor; the length, cost and
uncertain results of the company’s clinical trials, including any
additional clinical trials that the FDA may require in connection with
TX-004HR; the potential of adverse side effects or other safety risks
that could preclude the approval of the company’s hormone therapy drug
candidates; the company’s reliance on third parties to conduct its
clinical trials, research and development and manufacturing; 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: http://www.businesswire.com/news/home/20180308006277/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com