PDUFA target action date of May 29, 2018
BOCA RATON, Fla.--(BUSINESS WIRE)--Dec. 19, 2017--
TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare
company, today announced the acceptance of the New Drug Application
(NDA) resubmission for TX-004HR, the company’s investigational
applicator-free estradiol vaginal softgel capsule for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause, by the
U.S. Food and Drug Administration (FDA).
The FDA has acknowledged that the resubmission is a complete, class 2
response to the Complete Response Letter (CRL) received on May 5, 2017
for TX-004HR. The PDUFA target action date for the completion of the
FDA's review is May 29, 2018.
The FDA has informed the Company that the additional endometrial safety
information submitted to the NDA for TX-004HR on September 14, 2017 was
outside of an official review cycle, thus procedurally designating a
class 2 response. The Company currently plans to launch TX-004HR in the
third quarter of 2018 if approval occurs on or before the PDUFA target
action date.
“The acceptance of the NDA resubmission for TX-004HR is an important
milestone for TherapeuticsMD and this PDUFA target action date will
allow us to maintain our timelines for launch as early as July 2018,”
said TherapeuticsMD CEO Robert G. Finizio. “If approved, TX-004HR has
the potential to be a highly differentiated treatment option for the 32
million postmenopausal women in the United States who suffer from
symptoms of VVA.”
The 505(b)(2) NDA resubmission for TX-004HR is supported by the complete
TX-004HR clinical program, including positive results of the phase 3
Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4
mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.
The results demonstrated statistically significant and clinically
meaningful improvements in dyspareunia, a co-primary endpoint, and
vaginal dryness, a prespecified secondary endpoint. Statistically
significant results were seen as early as two weeks of treatment. The
NDA resubmission includes the 4 mcg and 10 mcg doses of TX-004HR.
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 phase 3 product
candidates: 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 company’s resubmitted NDA
for its TX-004HR product candidate; 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; whether the company will be able to
prepare an NDA for its TX-001HR product candidate and, if prepared,
whether the FDA will accept and approve the NDA; 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/20171219006286/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact:
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com