The multi-center, double-blind, placebo-controlled study was conducted in80 U.S. centers and involved 826 postmenopausal women. Fully 90% of women inthe study experienced moderate to severe vaginal dryness and 66% experiencedmoderate to severe dyspareunia. Following 12 weeks of treatment withOphena(TM), the decrease in the symptom score for patients reporting moderateto severe vaginal dryness was statistically significant as compared toplacebo. The symptom score for patients reporting moderate to severedyspareunia also showed a statistically significant decrease as compared toplacebo. Ophena(TM) was generally well tolerated and demonstrated a favorablesafety profile.
"For millions of post-menopausal women, the symptoms of vulvovaginalatrophy represent a serious health issue that can have a profound negativeimpact on quality of life. These results from the Phase 3 clinical trial forOphena(TM) show that a non-estrogen therapy may provide significant benefitsfor post-menopausal women affected by vaginal dryness and dyspareunia, two ofthe most common and debilitating symptoms of vulvovaginal atrophy," said JamesA. Simon, M.D., CCD, FACOG, Clinical Professor of Obstetrics and Gynecology atthe George Washington University.
Ophena(TM) is a novel selective estrogen receptor modulator (SERM) that isbeing studied as a non-estrogen alternative for the treatment ofpostmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. The onlyFDA approved products currently available to treat PVS contain the hormoneestrogen. Treatment with estrogen replacement therapy has been associated withcertain health risks including an increased risk of breast cancer.
"For women who are concerned about the health risks of estrogen therapy,currently available treatment options for symptoms of vulvovaginal atrophy arelimited and inadequate. These study results indicate that Ophena(TM) has thepotential to be the first non-estrogen treatment option that provides a clearclinical benefit. We are working to advance the development program forOphena(TM) to make this important therapy available to all women who wouldbenefit from it," said Robert Zerbe, M.D., president and chief executiveofficer of QuatRx.
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) is a chronic and progressivecondition characterized by symptoms including vaginal dryness, sexual pain(dyspareunia), and irritation. Declining estrogen levels during menopause cancause tissues of the vaginal lining to grow thinner and to lose elasticity, acondition known as atrophy. Dryness and irritation associated with reductionsin vaginal secretions often cause pain or bleeding during sexual intercourse.The decline in estrogen also contributes to an increase in vaginal pH,creating an environment more susceptible to infection. It is estimated that upto 45-75% of post-menopausal women have chronic symptoms of PVS. Currentprescription treatments approved for this condition all contain estrogen,administered e
