- 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 -
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 postmenopausal women.
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 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 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.
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TherapeuticsMD, Inc.Investor
ContactDavid DeLucia, 561-961-1900Director, Investor
RelationsDavid.DeLucia@TherapeuticsMD.comorSparkBioCommMedia ContactAmi Knoefler,
650-739-9952Ami@SparkBioComm.com
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