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 17β-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 17β-estradiol
and progesterone for oral use, was found to be similar to that of the
standard reference products for the human hormones estradiol (Estrace®)
and progesterone (Prometrium®), 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 17β-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 17ß-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: www.ReplenishTrial.com.
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® and BocaGreenMD™
brands.
More information is available at the following websites: www.therapeuticsmd.com,
www.vitamedmd.com,
www.vitamedmdrx.com,
and www.bocagreenmd.com.
vitaMedMD® and TherapeuticsMD® are registered
trademarks of TherapeuticsMD, Inc. BocaGreenMD™ 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 combination17β-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.
Copyright Business Wire 2013