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QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy
Date:5/21/2008

Results presented at 12th World Congress on the Menopause show significant improvement in vaginal dryness and dyspareunia, two of the most frequent

symptoms associated with vulvovaginal atrophy

ANN ARBOR, Mich., May 21 /PRNewswire/ -- QuatRx Pharmaceuticals today announced further positive data from a pivotal Phase 3 study of Ophena(TM) (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(TM) 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(TM) 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.

The multi-center, double-blind, placebo-controlled study was conducted in 80 U.S. centers and involved 826 postmenopausal women. Fully 90% of women in the study experienced moderate to severe vaginal dryness and 66% experienced moderate to severe dyspareunia. Following 12 weeks of treatment with Ophena(TM), the decrease in the symptom score for patients reporting moderate to severe vaginal dryness was statistically significant as compared to placebo. The symptom score for patients reporting moderate to severe dyspareunia also showed a statistically significant decrease as compared to placebo. Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile.

"For millions of post-menopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of
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SOURCE QuatRx Pharmaceuticals
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