QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
Published: Sep 24, 2008
ANN ARBOR, Mich., Sept. 24 /PRNewswire/ -- Additional results of a Phase 3 study for Ophena(TM) (ospemifene tablets) for the treatment of symptoms of vulvovaginal atrophy (VVA) in postmenopausal women showed that Ophena(TM) significantly improves a broad range of clinical signs of vulvovaginal atrophy, including petechiae, pallor, friability, vaginal dryness and redness in mucosa. These are all visual observations of VVA assessed during gynecological examination and were pre-defined secondary endpoints in the study. Results were announced today by QuatRx Pharmaceuticals in a poster presentation at the 19th Annual North American Menopause Society meeting in Orlando, Florida.
Vulvovaginal atrophy is a common and progressive condition associated with menopause. Earlier this year, QuatRx announced a Phase 3 study for Ophena(TM) met all four of its co-primary endpoints. The results of the study showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most bothersome symptoms associated with VVA. The study also demonstrated favorable effects of Ophena(TM) on vaginal wall health as compared to placebo, measured as changes in the proportion of parabasal and superficial cells in the vaginal epithelium, as well as a favorable effect on vaginal pH levels.
The multi-center, double-blind, placebo-controlled study was conducted at 80 U.S. centers and involved 826 postmenopausal women. The additional results announced today showed that after 12 weeks of treatment, the mean scores for common clinical signs of vaginal atrophy were decreased by a statistically significant margin in the Ophena(TM) groups when compared with placebo. These positive effects of Ophena(TM) were already evident at week 4, as the mean scores of all signs were significantly decreased by Ophena(TM) when compared to placebo. Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile in this study.
"Vulvovaginal atrophy represents a serious health issue that can have a profound negative impact on the quality of life for millions of postmenopausal women," said David Portman, M.D., director of the Columbus Center for Women's Health Research in Ohio. "These results show that Ophena(TM) has the potential to significantly improve multiple clinical signs of vaginal atrophy in symptomatic patients. These are significant results for a non-estrogen oral therapy and may pave the way for an alternative approach to a very common and concerning condition for postmenopausal women."
Also presented at the meeting were results from a study conducted by QuatRx which surveyed the prevalence and impact of vaginal atrophy symptoms and perceptions about the safety of treatment with estrogen. In a survey of 1038 postmenopausal women across the United States, Dr. Nanette Santoro, Albert Einstein College of Medicine, a key member of the research team, found that there was a high prevalence of vaginal atrophy symptoms among these women (overall 45%). The findings were consistent for both sexually active and non-sexually active respondents. A majority of women in the survey considered the symptoms of vaginal atrophy to be "bothersome." The study also showed a majority of women had either discontinued or never used hormone therapy due to concerns about health risks associated with estrogen and based on physician advice. The prevalence of vaginal atrophy symptoms was highest among women who either never used or discontinued estrogen treatment. Among women in the study who remained on estrogen therapy, a majority expressed concerns about long-term safety and 70% had been on treatment for five years or longer.
"These results shed new light on the prevalence and impact of vaginal atrophy among both sexually active and non-sexually active postmenopausal women, and confirm that there is a high degree of both awareness and concern about the health risks associated with estrogen therapy among these women," said Chris Nicholas, chief operating officer at QuatRx. "These data provide further support for the need for alternatives to estrogen for the treatment of vulvovaginal atrophy in the years ahead."
Ophena(TM) is a novel selective estrogen receptor modulator (SERM) that is being studied as a non-estrogen alternative for the treatment of vulvovaginal atrophy. The only FDA approved products currently available to treat VVA contain the hormone estrogen. Treatment with hormone therapy has been associated with certain health risks including an increased risk of breast cancer.
"These data are yet another confirmation that Ophena(TM) has the potential to be the first non-estrogen treatment option that provides a clear clinical benefit for postmenopausal women with vulvovaginal atrophy," said Robert Zerbe, M.D., president and chief executive officer of QuatRx. "We are working hard in our development efforts to provide women another choice for this highly prevalent and progressive condition."
About Vulvovaginal Atrophy
Vulvovaginal atrophy is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia), and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain and 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 up to 45-75% of post-menopausal women have chronic symptoms of VVA. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that are currently approved and marketed in the United States have not been shown to have beneficial effects on vaginal tissue and none are approved for use in treating symptoms of VVA.
QuatRx Pharmaceuticals is focused on the discovery, licensing, development and commercialization of compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to Ophena(TM), QuatRx has three other product candidates in active clinical development and an advanced preclinical program. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism in men. Sobetirome, a novel, selective thyroid receptor beta agonist, is in Phase 1 studies as a potential treatment for dyslipidemia. Asord(TM) (becocalcidiol), a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx's partner, Galderma. QuatRx's preclinical program is designed to address sex steroid dependent diseases through inhibition of 17beta-HSD enzymes. In Europe, QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, located in Turku, Finland. For press releases and other Company information, please visit www.quatrx.com.
CONTACT: Julia Owens of QuatRx Pharmaceuticals Company, +1-734-913-9900
Web site: http://www.quatrx.com/