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QUATRX PHARMACEUTICALS ANNOUNCES PRESENTATION OF FURTHER DATA FROM OPHENA (OSPEMIFENE) PHASE 3 STUDY FOR TREATMENT OF SYMPTOMS OF VULVOVAGINAL ATROPHYResults presented at the 12th World Congress on the Menopause show significant improvement in vaginal dryness and dyspareunia, two of the most frequent symptoms associated with vulvovaginal atrophy. [May 21, 2008] ANN ARBOR, MI—QuatRx Pharmaceuticals, today announced further positive data from a pivotal Phase 3 study of
Ophena (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 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 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.
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. About QuatRx 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, 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 (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.
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© 2008 QuatRx Pharmaceuticals Company Terms of Use |
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