QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vagin...( ANN ARBOR Mich. March 31 /- QuatRx ...),Health

ANN ARBOR, Mich., March 31 /PRNewswire/ -- QuatRx Pharmaceuticals, a privately-held biopharmaceutical company, today announced that it has completed enrollment in the Company's second pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene tablets). Together with the previously completed first pivotal Phase 3 study of Ophena(TM), the Company has fully enrolled its planned pivotal Phase 3 studies for Ophena(TM), the most advanced estrogen-free oral therapy currently in development for the treatment of vaginal symptoms associated with menopause. A total of more than 1,700 patients were enrolled in these two pivotal studies at sites across the U.S. In accordance with the study design, all enrolled patients have received their first dose of either Ophena(TM) or placebo in the second Phase 3 clinical trial. Due to the high level of interest from patients and physicians, the Company chose to exceed its enrollment target of 750 patients. The Company expects to complete the study in late summer-2009 and these data, together with results from the first phase 3 study, will complete the efficacy requirements for an NDA filing under the published FDA guidance for vaginal atrophy.

"We are pleased to have achieved this important development milestone in the development of Ophena(TM) and to have exceeded our enrollment goal in only seven months, in what we believe to be the largest vaginal atrophy study ever conducted," said Robert L. Zerbe, M.D., chief executive officer and president of QuatRx. "We believe that the high interest in this study indicates a substantial need for new therapies for the treatment of postmenopausal vaginal atrophy."

The randomized, double-blind study has enrolled over 900 postmenopausal women at 116 trial centers throughout the United States. Women in the study are being treated with either a 60mg once daily oral dose of Ophena(TM) or placebo over the 12-week trea
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