QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy
ANN ARBOR, Mich., May 21, 2008 /PRNewswire/ -- QuatRx Pharmaceuticals today announced further positive data from a pivotal Phase 3 study of Ophena(TM) (ospemifene tablets) to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. In January 2008, QuatRx announced positive top line results for the primary endpoints in the Phase 3 Ophena(TM) clinical trial, in which a statistically significant result in each of four co-primary endpoints was achieved. Results from this additional analysis of secondary endpoints of the Phase 3 study show that women treated with Ophena(TM) experienced improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most frequent symptoms associated with vulvovaginal atrophy. Results of this analysis were presented in an oral presentation today at the 12th World Congress on the Menopause in Madrid, Spain.
The multi-center, double-blind, placebo-controlled study was conducted in 80 U.S. centers and involved 826 postmenopausal women. Fully 90% of women in the study experienced moderate to severe vaginal dryness and 66% experienced moderate to severe dyspareunia. Following 12 weeks of treatment with Ophena(TM), the decrease in the symptom score for patients reporting moderate to severe vaginal dryness was statistically significant as compared to placebo. The symptom score for patients reporting moderate to severe dyspareunia also showed a statistically significant decrease as compared to placebo. Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile.
"For millions of post-menopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of life. These results from the Phase 3 clinical trial for Ophena(TM) show that a non-estrogen therapy may provide significant benefits for post-menopausal women affected by vaginal dryness and dyspareunia, two of the most common and debilitating symptoms of vulvovaginal atrophy," said James A. Simon, M.D., CCD, FACOG, Clinical Professor of Obstetrics and Gynecology at the .
Ophena(TM) is a novel selective estrogen receptor modulator (SERM) that is being studied as a non-estrogen alternative for the treatment of postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. The only FDA approved products currently available to treat PVS contain the hormone estrogen. Treatment with estrogen replacement therapy has been associated with certain 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 are limited and inadequate. These study results indicate that Ophena(TM) has the potential to be the first non-estrogen treatment option that provides a clear clinical benefit. We are working to advance the development program for Ophena(TM) to make this important therapy available to all women who would benefit from it," said Robert Zerbe, M.D., president and chief executive officer of QuatRx.
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) 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 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 up to 45-75% of post-menopausal women have chronic symptoms of PVS. 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 PVS.
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 for QuatRx, +1-734-913-9900 x121
Web site: http://www.quatrx.com/
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Posted: May 2008