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| Vagicap. Courtesy: TherapeuticsMD |
Vulvovaginal atrophy affects nearly half
of the postmenopausal women in the United States.[1] It
is often termed as ‘the silent epidemic’ as most of the women are reluctant to
seek medical advice due to cultural, social reasons. Adverse publicity of
Hormone Replacement Therapy(HRT) also plays a major role in preventing women
from discussing the symptoms with a healthcare professional.[2]
Results of a phase 3 REJOICE trial
investigating a novel drug delivery system for estradiol have shown promising results
in relieving symptoms of postmenopausal vulvovaginal atrophy.
This product which goes by the name of
TX-004HR is being developed by TherapeuticsMD, Inc, BOCA RATON, Florida.
The results from the pivotal phase 3 Rejoice Trial were presented at Endocrine
Society’s 98th Annual Meeting and Expo, being held April 1-4,
2016, in Boston and American College of Obstetricians and Gynecologists (ACOG)
Annual Clinical and Scientific Meeting held May 14-17, 2016, in Washington, DC.
TherapeuticsMD is using the unique
technology called ‘SYMBODA’ in manufacturing the softgel capsules conditionally
named as Yuvvexy™. SYMBODA, meaning “similar to the body,” is a
solubilized female hormone technology for formulation of estradiol and
progesterone identical in chemical structure to the estradiol
and progesterone that women naturally produce.[3] The drugs are dissolved in medium-chain oils
enabling content uniformity and accurate dosing. Vagicap is an applicator free,
vaginal-mucosal adhesive, soft gel capsule containing low-dose solubilized
17β-estradiol.[4]
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| Applicator free Vagicap . TherapeuticsMD |
The results of the trial were published
online in the forthcoming issue of Menopause. REJOICE was a randomized,
double-blind, placebo-controlled, phase 3 study of 764 postmenopausal women who
complaint of bothersome dyspareunia and vulvovaginal atrophy (VVA). They were
treated with 4, 10, or 25 [mu]g TX-004HR or placebo for 12 weeks. Women
received treatment once daily for 2 weeks, then twice weekly for 10 weeks.
Female Sexual Function Index (FSFI)
questionnaire were administered to all the participants at baseline and at 12
weeks. It consists of 19 questions covering six domains of sexual function.
Significant improvement was seen (P
< 0.0001) in co-primary endpoints of percentages of superficial and
parabasal cells, vaginal pH other than dyspareunia at 2 weeks.
Dyspareunia, vaginal dryness and irritation
all improved at the end of study. FSFI scores also showed a significant improvement
with all the doses of TX-004HR.
The drug was well tolerated with no
serious side effects. Blood levels of estradiol remained at pretreatment level
throughout the study.
The authors concluded that “The present Female Sexual Function Index (FSFI)
data coupled with improvement in vaginal physiology suggest that TX-004HR could
be a promising treatment option for VVA, with a potential added benefit of
improving Female Sexual Dysfunction (FSD) in postmenopausal women.
Dr
Bernick, Julia M. Amadio and Sebastian Mirkin, MD are employed by
TherapeuticsMD.
[1] http://www.endocrinologyadvisor.com/endo-2016/endo-vaginal-capsule-may-relieve-vulvar-vaginal-atrophy/article/490044/
[2] https://core.ac.uk/download/pdf/36770934.pdf
[3] https://www.therapeuticsmd.com/research/symboda-technology
[4] http://www.sciencedirect.com/science/article/pii/S1743609516304040
