Novel non-estrogen oral therapy in development for menopausal symptoms
ANN ARBOR, Mich., Jan. 3 /PRNewswire/ -- QuatRx Pharmaceuticals Company today announced positive results from a pivotal Phase 3 study of Ophena(TM) (ospemifene) to treat postmenopausal women with vulvovaginal atrophy, a common condition associated with menopause. Top line data show that the multi-center, double-blind, placebo-controlled study successfully met all of its co-primary endpoints. The study was conducted in 80 U.S. centers and involved more than 800 women. Full results of the study are being submitted to an upcoming scientific meeting for release later in 2008.
Ophena(TM) is a novel selective estrogen receptor modulator (SERM) that is being studied as a treatment for women with postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. PVS is a common condition in postmenopausal women characterized by symptoms such as vaginal dryness, irritation and pain associated with sexual intercourse. The only currently FDA approved products for this condition all contain the hormone estrogen. However, many women and their physicians avoid using estrogen-containing products due to concerns about the risks of such therapy identified in the Women's Health Initiative (WHI) and other studies.
"These results are very exciting and we believe demonstrate that Ophena(TM) has the potential to bring clear clinical benefit to women affected by PVS, many of whom have had only estrogen therapy as a treatment option for their condition to date," said Robert L. Zerbe, M.D., chief executive officer and president of QuatRx. "We believe Ophena(TM) could provide the first non- estrogen prescription treatment alternative for this condition. QuatRx is well positioned to continue with our plans to advance this exciting product to commercialization, pending regulatory review and approval."
This pivotal Phase 3 study was designed to evaluate the efficacy of
Ophena(TM) versus p
|SOURCE QuatRx Pharmaceuticals Company|
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