-TherapeuticsMD Donates Award Money to NAMS-
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NYSE MKT: TXMD)
announced today that it received the first-place prize for its poster at the The
North American Menopause Society (NAMS) 2013 Annual Meeting recently held in
Dallas. The poster detailed findings on the first investigational combination
17b-estradiol and progesterone capsule that may have overcome the
well-recognized difficulties of achieving good bioavailability with oral
administration of these hormones in combination. TherapeuticsMD is developing
this compound, TX 12-001-HR, for FDA review.
Bioavailability of TX 12-001-HR, a capsule containing both 17b-estradiol and
progesterone for oral use, was found to be similar to that of the standard
reference products for the human hormones estradiol (Estrace(R)) and
progesterone (Prometrium(R)), when taken concurrently. The poster, which was
presented by James H. Pickar, M.D., Adjunct Associate Professor of Obstetrics
and Gynecology, Columbia University College of Physicians & Surgeons in New
York, described findings from a phase 1 study.
"NAMS congratulates TherapeuticsMD on its poster design award. Its poster was
selected by an independent poster review committee. NAMS is pleased that so many
outstanding research posters on women's health and menopause were presented at
our annual meeting," said Dr. Margery Gass, executive director of The North
American Menopause Society.
Posters were evaluated on the basis of five criteria: appropriateness of study
design, whether the conclusion flows from the results, overall quality of the
science, impact of the study on the field of menopause, and visual appeal of the
poster. Each category was rated on a 1-to-5 scale, with 1 = poor, 2 = fair, 3 =
satisfactory, 4 = good, and 5 = excellent. The total score for each poster was
the sum of the scores given for each of the criteria. Each poster was judged by
three experts. The 113 poster presentations evaluated by a judging panel of 23
medical experts were eligible for up to four prizes, with first- and
second-place winners receiving cash awards. TherapeuticsMD donated its
first-place prize of $1,000 to NAMS.
"We are very pleased by this recognition among so many top-quality submissions.
It is a testament to the dedication of our research team and a reflection of our
commitment to develop innovative hormone therapies that fill the critical need
for better treatments in the hormone and women's health market. Using our
technology to enable the delivery of body-identical hormones through a variety
of dosage forms and administration routes, we hope to reverse what we believe
has been a long-standing innovation gap in women's health," said Robert Finizio,
Co-Founder and Chief Executive Officer of TherapeuticsMD.
About the Study
The study, which was sponsored by TherapeuticsMD, Inc., was designed to
determine the pharmacokinetics and bioavailability of its combination capsule of
17b-estradiol and progesterone (test drug: TX 12-001-HR). Participants included
66 healthy, postmenopausal women, age 40-65 years. Each participant was randomly
assigned to begin one of three dosing sequences, each including three periods.
During one period participants received a single dose of the test drug, and
during two periods they received single doses of both the estradiol and
progesterone reference drugs, which were taken concurrently. Blood samples were
collected at multiple intervals, beginning one hour prior to start of dosing and
continuing to 48 hours after dosing. Bioavailability was determined by measuring
the rate and extent of absorption of the drugs.
About Hormone Therapy
Menopausal hormone therapy (HT) is the administration of hormones to treat
menopausal symptoms resulting from a lack of naturally occurring hormones.
Current HT options include FDA-approved combination products, FDA-approved
estrogen-only and progestogen-only products, and non-FDA approved compounded
bioidentical products. A body-identical combination product, which exactly
matches the molecular structure of the human hormones estradiol and
progesterone, is being developed by TherapeuticsMD and is currently in phase 3
clinical trials. HT is projected to be the largest growth segment in the overall
women's health market. The potential market for pharmacy-compounded,
bioidentical HT products is estimated to be approximately $1.5 billion per year.
About TX 12-001HR
TX 12-001-HR is a body-identical investigational drug designed to treat
menopausal symptoms by replacing the 17 -estradiol and progesterone hormones the
body has stopped producing as the result of menopause. Enrollment is currently
under way in the REPLENISH Trial, a phase 3, investigational research study made
up of 1,550 patients to evaluate the safety and efficacy of TX 12-001-HR in
reducing the symptoms of menopause. For more information, please visit:
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women's healthcare company focused on developing and
commercializing products targeted exclusively for women. We are currently
developing advanced hormone therapy pharmaceutical products designed to
alleviate the symptoms of and reduce the health risks resulting from
menopause-related hormone deficiencies. We are also evaluating various other
potential indications for our hormone technology, including oral contraception,
preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.
Additionally, our business includes the manufacture and distribution of branded
and generic prescription prenatal vitamins, as well as over-the-counter vitamins
and cosmetics, under our vitaMedMD(R) and BocaGreenMD(TM) brands.
More information is available at the following websites: www.therapeuticsmd.com,
www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
vitaMedMD(R) and TherapeuticsMD(R) are registered trademarks of TherapeuticsMD,
Inc. BocaGreenMD(TM) is a trademark of TherapeuticsMD, Inc.
Except for the historical information contained herein, the matters set forth in
this press release, including statements regarding the continuation and ultimate
results of clinical development of the Company's proposed
combination17b-estradiol and progesterone drug, the Company's commitment to
develop innovative hormone therapies to fill a critical need in the hormone and
women's health market, the Company's intention and the means used to reverse
what it believes is a long-standing innovation gap in women's health, the use of
hormone therapy to alleviate the symptoms of menopause and to reduce the health
risks resulting from hormone deficiencies associated with menopause, the
anticipated achievements, attributes, and benefits of TX 12-001HR, what the TX
12-001HR clinical trial is designed to measure, and the potential size of the
market for pharmacy-compounded, bioidentical products are forward-looking
statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to differ
materially, including but not limited to: timely and successful completion of
clinical studies and the results thereof; risks and uncertainties associated
with the Company's business and finances in general; and other risks detailed in
the Company's filings with the U.S. Securities and Exchange Commission including
its annual report on Form 10-K, reports on Form 10-Q and Form 8-K, and other
such filings. These forward-looking statements are based on current information
that may change. Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this press
release. All forward-looking statements are qualified in their entirety by this
cautionary statement, and the Company undertakes no obligation to revise or
update any forward-looking statement to reflect events or circumstances after
the issuance of this press release.
Dan Cartwright, 561-961-1930
Chief Financial Officer
In-Site Communications, Inc.
Lisa M. Wilson, 917-543-9932
Red Fox Communications
Judy Grossman, 917-913-1690
Source: TherapeuticsMD, Inc.