A New Drug May Help Relieve Menopausal Vulvar and Vaginal Atrophy Symptoms
It’s no question how much innovations and new discoveries in healthcare have helped in the delivery of quality care to patients. Those which were once deemed as impossible are now possible. Technology has made patient care much more effective and efficient, helping both patient and the healthcare provider. And wait, there’s more. A new drug discovered may just be the answer for those experiencing menopausal vulvar and vaginal atrophy symptoms.
According to new industry-sponsored research reports, a new low-dose vaginal estrogen capsule may help relieve symptoms of menopausal vulvar and vaginal atrophy, including dyspareunia, which is pain during sex. The study results was presented in a late-breaking poster last Saturday, April 2, at ENDO 2016, the annual meeting of the Endocrine Society, in Boston.
A new “easy to use” option for vulvar and vaginal atrophy
Statistics show that roughly 50 percent or 32 million of postmenopausal women in the United States is affected by Vulvar and vaginal atrophy. This widespread condition involves decreased estrogenization of vaginal tissue and can cause painful sexual activity and urination, vaginal dryness, itching and irritation.
According to study consultant and lead author Ginger D. Constantine, MD, who is also the president and CEO of EndoRheum Consultants, LLC, in Malvern, Pennsylvania, “this study provides a new easy-to-use option for vulvar and vaginal atrophy, for which only about 7 percent of women are currently treated with a prescription product. Health care providers and their patients may soon have an additional safe and effective product for a very untreated condition.”
TX-004HR, which contains the estrogen 17?-estradiol, is currently an investigational drug for use in clinical trials and is not yet available to the general public.
TherapeuticsMD, the manufacturer of TX-004HR, conducted the double-blind, randomized, phase 3 REJOICE clinical trial comparing 3 doses (4, 10, and 25 micrograms) of TX-004HR with placebo in 764 postmenopausal women aged 40 through 75 in 105 medical centers in the United States and Canada.
The women included in the study received either vaginal softgel capsules containing one of the three doses of TX-004HR or placebo, once daily for two weeks, then twice weekly for 10 weeks. The vaginal cells and vaginal pH significantly improved within two weeks at all doses, compared with placebo. Superficial and parabasal vaginal cell improvement was found at baseline and at two, six, eight and 12 weeks, and at every time point the return to premenopausal cell ratios was significant. Vaginal pH returned to premenopausal levels as well. Dyspareunia, vaginal dryness and irritation, significantly improved.
TX-004HR did not, however, on average, increase blood levels of estradiol outside the normal postmenopausal range.
The treatment was well tolerated as there were no treatment-related serious adverse events reported, as well as there were no clinically significant differences found in any adverse events or treatment-related serious adverse events between TX-004HR and placebo.
TherapeuticsMD plans to use the results of this study in its new drug application for approval of TX004HR to the FDA that will be submitted during the first half of 2016.