TherapeuticsMD Presents Detailed Results from Phase 3 Rejoice Trial in Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) at ENDO 2016
TX-004HR Showed Statistically Significant Improvements in Dyspareunia
(Vaginal Pain During Sexual Intercourse) and Vaginal Dryness at All
Doses (25 mcg, 10 mcg and 4 mcg)
Pharmacokinetics Substudy Showed Negligible to Very Low Systemic
Absorption of 17β-Estradiol
BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, presented detailed results from the pivotal phase 3 Rejoice
Trial for its TX-004HR product candidate in two late-breaking posters at
the Endocrine Society’s 98th Annual Meeting and Expo, being
held April 1-4, 2016, in Boston. TX-004HR is an applicator-free vaginal
estradiol softgel capsule being investigated for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of VVA due to menopause. Abstracts for the two posters, “The
Rejoice Trial: A Phase 3 Randomized Controlled Trial Evaluating the
Safety and Efficacy of a Novel Vaginal Estradiol Softgel Capsule for
Symptomatic Vulvar and Vaginal Atrophy (VVA)” and “TX-004HR
Vaginal Estradiol Effectively Treats Vulvar and Vaginal Atrophy (VVA)
with Negligible to Low Systemic Absorption” have been published
online by the Endocrine Society. VVA is a chronic and progressive
condition that affects nearly half of postmenopausal women in the United
States.
Detailed results from the Rejoice Trial, a randomized, double-blind,
placebo-controlled, multicenter, phase 3 study of TX-004HR at 25 mcg, 10
mcg and 4 mcg doses in postmenopausal women with a moderate-to-severe
dyspareunia, showed that at week 12, all TX-004HR doses compared with
placebo significantly improved the four co-primary endpoints, including
vaginal superficial cells, vaginal parabasal cells, vaginal pH, and the
severity of dyspareunia (all p<0.00001 except dyspareunia at 4
mcg p=0.0149). Moreover, the changes in cytology, pH, and
dyspareunia were significant at all intermediate time points (weeks 2,
6, and 8). The Rejoice Trial secondary endpoint result for vaginal
dryness was also statistically significant for all three doses
evaluated, as moderate-to-severe vaginal dryness was reported by 93% of
patients at baseline, and was significantly improved (p<0.02) for
all doses at weeks 2, 6, 8, and 12 (except the 4 mcg dose at week 2). A
post-study patient questionnaire showed TX-004HR had high patient
acceptability and satisfaction. TX-004HR was well tolerated; the most
frequently reported treatment-emergent adverse events (AEs) were
headache, vaginal discharge, nasopharyngitis and vulvovaginal pruritus.
Vaginal discharge and vulvovaginal pruritus were numerically higher in
the placebo group. No clinically significant differences in AEs between
treatment and placebo groups were observed.
“The Rejoice Trial data demonstrated clinically meaningful improvements
for postmenopausal women suffering from symptoms of VVA,” said
TherapeuticsMD Chief Clinical Officer Brian Bernick, M.D., “With these
positive data for both dyspareunia and vaginal dryness, which achieved
statistical significance as early as two weeks with high user
satisfaction rates, we strongly believe in TX-004HR as a promising
potential treatment option for the millions of postmenopausal women
suffering with VVA.”
The results from the pharmacokinetics (PK) sub-study of TX-004HR were
also presented at ENDO 2016. The three doses of TX-004HR showed
negligible to very low systemic absorption of estradiol. Safety
parameters further revealed no significant differences in estrogen
sensitivity tests and no signals of estrogenic stimulation of the
endometrium.
“The Rejoice Trial data demonstrated that despite the low systemic
absorption of estradiol, all doses of TX-004HR improved dyspareunia and
dryness due to VVA, which I consider to be an excellent profile for a
local estradiol treatment,” said Dr. David F. Archer, lead author of the
PK substudy and Professor of Obstetrics and Gynecology at Eastern
Virginia Medical School (EVMS) in Norfolk, VA.
TherapeuticsMD plans to use the Rejoice Trial data as the basis for a
New Drug Application to the Food and Drug Administration (FDA) for
TX-004HR. The company has also received conditional approval from the
FDA for the brand name Yuvvexy™ for TX-004HR.
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.
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forward-looking statements. Forward-looking statements may include, but
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that address activities, events or developments that the company
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assessments made in light of management’s experience and perception of
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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; 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.
Contacts
TherapeuticsMD, Inc.
Investors
Dan
Cartwright, 561-961-1900
Chief Financial Officer
Dan.Cartwright@TherapeuticsMD.com
or
Media
WCG
Elliot
Fox, 212-257-6724
Director, Media & Engagement
efox@w2ogroup.com
