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QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome
Date:1/3/2008

lacebo 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 gr
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SOURCE QuatRx Pharmaceuticals Company
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