TherapeuticsMD Completes Enrollment in Phase 3 Clinical Trial of Bio-identical Oral Combination of Estradiol and Progesterone Product Candidate

13 Oct 2015, 06:00 AM EDT

Study evaluates TX-001HR, first bio-identical combination product
candidate to treat vasomotor symptoms of menopause

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced that the company has completed patient
enrollment in the Replenish Trial, a phase 3 clinical trial evaluating
multiple doses of the investigational once-daily oral softgel capsule,
TX-001HR (estradiol and progesterone), to reduce the frequency and
severity of moderate to severe vasomotor symptoms (VMS), including hot
flashes and night sweats, in postmenopausal women.

TherapeuticsMD believes TX-001HR, if approved by the FDA, would
represent the first time estradiol and progesterone (bio-identical to
the estradiol and progesterone produced by a woman’s ovaries), would be
approved for use in a single, combined product. Patented TX-001HR was
developed with SYMBODA™, an advanced technology for solubilizing the
bio-identical hormones 17β-estradiol and progesterone.

“There are currently no FDA-approved oral bio-identical estradiol and
progesterone combination products for women experiencing hot flashes and
night sweats. Approximately 1 million to 2.5 million women are currently
estimated to use non FDA-approved compounded menopausal hormone therapy
in the U.S. TherapeuticsMD seeks to address the unmet needs of
post-menopausal women as we develop potentially the first FDA-approved
17β-estradiol plus progesterone combination softgel capsule in the
United States,” stated Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD. “Completion of patient recruitment in the Replenish
Trial marks an important milestone in our development efforts and
illustrates continued progress towards our goal of bringing novel
hormone therapy options to women.”

Trial Design

A pivotal safety and efficacy study, the Replenish Trial is a
prospective, randomized, double-blind, placebo-controlled,
parallel-group, multicenter study evaluating four doses of TX-001HR:
combined estradiol 1 mg/progesterone 100 mg; combined estradiol 0.5
mg/progesterone 100 mg; combined estradiol 0.5 mg/progesterone 50 mg;
and combined estradiol 0.25 mg/progesterone 50 mg. If approved, each of
these combinations of estradiol and progesterone doses would represent a
lower daily dose of estradiol and/or progesterone than those in
currently approved products. The 12-month trial enrolled more than 1,750
healthy postmenopausal women (age 40 to 65 years old) in approximately
110 sites across the United States. The primary efficacy objective is to
determine whether TX-001HR given daily is effective at reducing the
frequency and severity of moderate to severe vasomotor symptoms
associated with menopause when compared to placebo treatment at weeks 4
and 12. The Replenish Trial will also evaluate whether ongoing treatment
with TX-001HR given daily is effective at achieving a ≤1% incidence rate
of endometrial hyperplasia following 12 months of therapy (primary
safety objective).

About SYMBODA Technology

SYMBODA, meaning “similar to the body,” is a technology for formulation
of solubilized hormones identical in chemical structure (bio-identical)
to the estradiol and progesterone women naturally produce.
TherapeuticsMD is leveraging this leading-edge technology to create new
bio-identical drug forms and combinations that are designed to meet FDA
uniformity and stability requirements.

About Hormone Therapy (also referred to as Hormone Replacement
Therapy or Menopausal Hormone Therapy)

Hormone Therapy (HT) is the administration of hormones to treat
menopausal symptoms that arise from a reduction of naturally occurring
hormones. Current HT options include FDA-approved combination products
using non-bio-identical hormones, FDA-approved estrogen-only and
progestogen-only products and non-FDA approved compounded bioidentical
products. According to Symphony Health Solutions, the current market for
FDA-approved combination HT products is approximately $661 million
annually, while various sources estimate that pharmacy-compounded,
bioidentical HT product sales are approximately $1.5 billion annually.

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 clinical development pipeline includes two phase 3
products. The company also manufactures and distributes branded and
generic prescription prenatal vitamins as well as over-the-counter
vitamins under the vitaMedMD^® and BocaGreenMD^®
brands. More information is available at the following websites: www.therapeuticsmd.com,
www.vitamedmd.com,
www.vitamedmdrx.com
and www.bocagreenmd.com.

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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; 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
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