QuatRx Pharmaceuticals Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy
7/29/2009 8:46:26 AM
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.
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