TherapeuticsMD Inc (NYSEMKT:TXMD) is making some impressive gains today, currently 64 cents, or 11 percent, higher at $6.58 in early-afternoon trading. The surge came after the drug maker announced that it will publish a manuscript detailing its estrogen therapy clinical study in a collection of scholarly articles called “Menopause: The Journal of The North American Menopause Society.”
The stock’s volume is also being boosted today, with more than 4.0 million shares already traded since this morning. On an average trading day, only about 2.5 million shares of TherapeuticsMD change hands.
According to a press release that TherapeuticsMD made public after the market close yesterday, the manuscript will be called “Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women’s Health Initiative Observational Study.” It is the first big prospective observational trial that assesses the general health risks and advantages of vaginal estrogen therapy.
The study that the manuscript is a part of was conducted over a long period of time – between 1993 and 2005. Nearly 100,000 postmenopausal women were enrolled in the wider program, giving reliable estimates on how much known risk factors are indicators of future heart disease, bone fractures and cancers.
The study that will be detailed in the manuscript assessed more than 4,000 women who had been treated with vaginal estrogen for a median length of two to three years. The results showed that there was no meaningful difference in the risk of stroke, endometrial cancer, invasive breast cancer, colorectal cancer, and venous thromboembolism for patients using vaginal estrogen compared to nonusers.
The research also demonstrated that, with patients who still had an intact uterus, there was a reduced risk of hip fracture, cardiovascular disease and all-cause mortality in patients being treated with vaginal estrogen compared to those who weren’t.
“This is the first study identifying the real world use of vaginal estrogen and the associated risks and benefits,” said the company’s Chief Medical Officer, Sebastian Mirkin. “We believe that these data, which includes two to three years of median duration of use of vaginal estrogen products, should address the only approvability issue raised by the FDA for TX-004HR – the lack of long-term endometrial safety data beyond the 12 weeks studied in the REJOICE trial.”
The author of this article holds no position in any of the companies mentioned above.