QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vagin...( ANN ARBOR Mich. J...),Health

ANN ARBOR, Mich., July 29 /PRNewswire/ -- QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive top-line efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy. Ophena(TM) is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause.

"We are delighted with the progress in our Phase 3 program of Ophena(TM), which provides further evidence of the potential of Ophena(TM) as a first-in-class non-estrogen drug for the treatment of vaginal atrophy, a highly prevalent and symptomatic condition" said Robert L. Zerbe, M.D., Chief Executive Officer of QuatRx. "These new efficacy data confirm results seen in our first phase 3 pivotal study and are an important milestone towards our planned NDA submission."

This second Phase 3 study of Ophena(TM) is a randomized, double-blind, placebo-controlled trial of 919 patients with vulvovaginal atrophy conducted at 116 sites in the United States. Patients were stratified into two cohorts based on their most bothersome moderate to severe vaginal atrophy symptom - either vaginal dryness or dyspareunia (sexual pain). The results announced today focus on the cohort of 314 patients from this study identifying vaginal dryness as their m
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