- Results of the Replenish Trial show positive safety and efficacy
of TX-001HR as the first potential bio-identical
combination treatment for vasomotor symptoms in menopausal women -
BOCA RATON, Fla.--(BUSINESS WIRE)--Apr. 3, 2017--
TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced that data on TX-001HR, an investigational
bio-identical hormone therapy combination of 17ß-estradiol and
progesterone in a single, oral softgel, for the treatment of moderate to
severe vasomotor symptoms (VMS) due to menopause, was presented at ENDO
2017, the annual meeting of the Endocrine Society in Orlando, Florida,
April 1-4. The positive results of the pivotal phase 3 Replenish Trial
data were featured in an oral and a poster presentation.
In the oral presentation today, Rogerio Lobo, M.D., professor of
Obstetrics and Gynecology and Director of the Reproductive Endocrinology
Program at Columbia University, reviewed the detailed findings from the
Replenish Trial, the phase 3 study that evaluated the safety and
efficacy of four doses of TX-001HR. The Replenish Trial demonstrated
that two doses of TX-001HR (estradiol 1 mg/progesterone 100 mg and
estradiol 0.5 mg/progesterone 100 mg) achieved a statistically
significant and clinically meaningful reduction in both the frequency
and severity of hot flashes compared to placebo at weeks 4 and 12,
meeting all the co-primary efficacy endpoints.
Secondary endpoint data presented by Dr. Lobo also showed statistically
significant improvement in both total and vasomotor menopause specific
quality-of-life questionnaire (MENQOL) scores at week 12 and maintained
through six and 12 months for these two doses of TX-001HR, further
supporting the primary efficacy data shown in the Replenish Trial.
MENQOL is a validated tool used to measure quality-of-life in
Dr. Lobo commented, “I am pleased to finally see evidence from a
well-controlled trial supporting the use of defined doses of
bio-identical estradiol and progesterone in combination to treat VMS.
These study data, including both the primary and secondary endpoints,
suggest that, if approved, TX-001HR will be a valuable new treatment
option for women suffering from symptoms of menopause.”
Additionally, David Archer, M.D., professor of Obstetrics and Gynecology
and Director of Clinical Research at the Jones Institute at Eastern
Virginia Medical School, presented a poster that analyzed endometrial
safety in the Replenish Trial. The data showed that TX-001HR resulted in
no cases of endometrial hyperplasia or malignancy (0 percent) in all
treatment groups, meeting the recommendations established by the U.S.
Food and Drug Agency’s (FDA) draft guidance.
The most common adverse events in the Replenish Trial (>5 percent)
reported on average in all the active treatment groups were headache,
nasopharyngitis, breast tenderness, and upper respiratory infection.
There were no unexpected safety signals.
“TX-001HR is the first bio-identical combination hormone therapy of
estradiol and progesterone to demonstrate safety and efficacy data in a
large, well-controlled, randomized clinical trial,” said TherapeuticsMD
Chief Medical Officer Sebastian Mirkin, M.D. “If approved, TX-001HR
would provide a validated new treatment option for the millions of
postmenopausal women who are currently taking unapproved compounded
hormones for the treatment of moderate to severe vasomotor symptoms.”
Both the oral and poster presentations from ENDO 2017 are available in
the “Investors & Media” section of the company’s website at www.therapeuticsmd.com.
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
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 its hormone therapy drug candidates and obtain additional
financing necessary therefor; whether the company will be able to
prepare a new drug application for its TX-001HR product candidate and,
if prepared, whether the FDA will accept and approve the application;
whether the FDA will approve the company’s new drug application for its
TX-004HR product candidate and whether any such approval will occur by
the PDUFA date; the length, cost and uncertain results of the company’s
clinical trials; 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/20170403006339/en/
Source: TherapeuticsMD, Inc.
Director, Investor Relations
Ami Knoefler, 650-739-9952