ANN ARBOR – QuatRx Pharmaceuticals on Monday announced detailed primary endpoint results from Phase 3 clinical trial of Ophena (ospemifene tablets) to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. The successful trial brings QuatRx once step closer to commercialization.

The study, the company said, successfully met all four co-primary endpoints. Women treated with Ophena at the 60 mg dose showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels.

Results of this Phase 3 clinical trial were presented today in a poster presentation at the 90th annual Endocrine Society meeting in San Francisco.

The decline in estrogen levels in women after menopause is associated with an increase in vaginal pH levels as well as a thinning of the vaginal wall, resulting in bothersome symptoms such as vaginal dryness and painful intercourse.

In the Phase 3 Ophena clinical study, women were asked to identify their most bothersome symptom of vaginal atrophy. The co-primary endpoints were defined as the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and improvements in the most bothersome moderate to severe vulvovaginal atrophy symptom.

�??Vaginal atrophy symptoms in postmenopausal women are usually progressive and, unlike hot flashes, do not resolve spontaneously,�?� said Dr. Gloria A. Bachmann, Associate Dean for Women�??s Health and Professor of Ob/Gyn & Medicine at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School.

�??They can have a significant impact on a woman�??s quality of life. These Phase 3 clinical study results indicate that this new oral tablet has the potential to address the most common and debilitating chronic symptoms of vaginal atrophy for millions of women in the years ahead.�?�

The study investigated treatment with Ophena administered orally, once-daily at 30 and 60 mg doses as compared to a placebo. Women were randomized (1:1:1) into a double-blind 12-week treatment period with a four-week follow-up or the opportunity to continue in a long-term safety extension study. All women were supplied with a non-hormonal vaginal lubricant to be applied as needed during the 12-week treatment period.

�??These Phase 3 clinical study results also show that treatment with Ophena has the potential to offer advantages in addition to the use of vaginal lubricants,�?� said Robert Zerbe, MD, QuatRx CEO. �??There are currently no prescription alternatives available for postmenopausal women with symptoms of vaginal atrophy who are concerned about the risks of treatment with estrogen. Over-the-counter vaginal lubricants may help temporarily ease some symptoms of vulvovaginal atrophy associated with intercourse for some women, but they do not treat the underlying progressive condition which is the source of these chronic vaginal symptoms.�?�

Ophena, a novel selective estrogen receptor modulator (SERM), is being studied as a nonestrogen alternative for the treatment of symptoms of postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. The only FDA approved prescription products currently available to treat PVS contain estrogen. Treatment with estrogen therapy has been associated with certain

health risks, and many women prefer non-estrogen alternatives.

For more information, click on Quatrx.Com

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