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QUATRX INITIATES SECOND PHASE 3 STUDY OF OPHENA (OSPEMIFENE TABLETS) IN WOMEN WITH POSTMENOPAUSAL VAGINAL SYNDROMEPivotal Study Seeks to Enroll 750 Women at More Than 100 Sites in the U.S. [September 4, 2008] ANN ARBOR, MI—QuatRx Pharmaceuticals, a privately-held biopharmaceutical company focused on development and
commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders, today announced that it has initiated a second Phase 3 clinical
trial of Ophena (ospemifene tablets), the company’s estrogen-free oral therapy in development for the treatment of vaginal symptoms associated
with menopause.
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. It is estimated that 45-75 percent of post-menopausal women experience 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 as a potential treatment for dyslipidemia. 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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