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 placebo over a 12-week treatment period in women with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. A total of 826 women were enrolled in the study.
The primary endpoints for the Phase 3 Ophena(TM) clinical trial were defined as the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and the most bothersome moderate to severe vulvovaginal atrophy symptom, consistent with the appropriate FDA guidance. Top-line data indicate that the study achieved a statistically significant result in each of these co-primary endpoints and that Ophena(TM) was well tolerated.
The study investigated two doses of Ophena(TM) versus placebo, administered once daily, with patients randomized (1:1:1) into a double-blind 12-week treatment period with a four-week follow-up or the opportunity to continue in a long-term safety extension study. All subjects were supplied with a non-hormonal vaginal lubricant to be applied as needed during the 12- week treatment period.
Rochelle Hanley, M.D., chief medical officer of QuatRx Pharmaceuticals, added, "Based on this study, we believe Ophena(TM) is the first drug to demonstrate efficacy in this population over and above the use of topical lubricants. These are important new data that underscore the clinical benefit Ophena(TM) could provide for this common chronic condition."
The full data set from the study is currently being analyzed and will be submitted for presentation at an upcoming scientific meeting and for publication in an appropriate peer-reviewed setting.
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) is a chronic 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 40% of post-menopausal women have 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 this condition.
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 two preclinical development programs. 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. QRX-431, a novel, selective thyroid receptor beta agonist, is in Phase 1 studies as a potential treatment for lipid disorders and obesity. Asord(TM) (becocalcidiol), a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx's partner, CollaGenex Pharmaceuticals, Inc. QuatRx's two preclinical small molecule programs are designed to address common endocrine disorders in women and men. 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.
SOURCE QuatRx Pharmaceuticals Company