Applicator-free novel vaginal estradiol softgel capsule promising in relieving vaginal atrophy.

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 98^th 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]

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.

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[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