QuatRx Announces Positive Results of Second Pivotal Phase 3 Clinical Study for Ophena(TM) (Ospemifene Tablets) in Treatment of Postmenopausal Vagin...(er of QuatRx. With the completion of ou...),Health

Date:9/10/2009

er of QuatRx. "With the completion of our second pivotal Phase 3 study, we believe we have now fully confirmed the efficacy of Ophena according to the criteria established by FDA under the applicable guidance for this indication. Based on this, we are working aggressively to move forward with our NDA submission and to bring this promising new treatment option to the millions of women affected by vaginal atrophy who want an alternative to estrogen therapy."

The company's planned NDA for 2010 will seek regulatory approval for Ophena(TM), a new SERM (selective estrogen receptor modulator), for the treatment of the symptoms of postmenopausal vulvovaginal atrophy. Ophena(TM) is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause.

In January 2008, QuatRx announced results from the first Phase 3 study for Ophena(TM). These results confirmed that women treated with Ophena(TM) at the 60 mg dose showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels. In July 2009, QuatRx announced results from the first patient cohort involved in the second Phase 3 study. Among 314 patients identifying vaginal dryness as their most bothersome symptom, the study showed efficacy in all four co-primary endpoints, confirming the results seen in the first pivotal Phase 3 study of Ophena(TM). The results also demonstrated that Ophena(TM) was well-tolerated.

Phase 3 Long-Term Safety Update

QuatRx has also recently completed its long term safety program for Ophena(TM). This included two safety extensions from the first pivotal Phase 3 study, together with a placebo contr
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SOURCE QuatRx Pharmaceuticals Company Copyright©2009 PR Newswire. All rights reserved

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