Phase 3 study update of Ophena for postmenopausal vaginal atrophy

QuatRx Pharmaceuticals announced positive top-line efficacy results from its second pivotal Phase 3 trial of the investigational compound, Ophena (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). This second study 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). These announced results focus on the cohort of 314 patients from this study identifying vaginal dryness as their most bothersome symptom. The positive efficacy results in this cohort, achieved in all four co-primary endpoints, confirm the results seen in the first pivotal Phase 3 trial of Ophena. These results showed statistically significant changes from baseline to week 12 compared to placebo in four co-primary endpoints: the percentages of both parabasal cells and superficial cells in the vaginal maturation index, changes in vaginal pH (all p<0.001) and improvements in the most bothersome symptom of vaginal dryness (p=0.01 on a per protocol analysis).

Ophena, a selective estrogen receptor modulator (SERM), is available as an estrogen-free oral therapy.  QuatRx expects to file a New Drug Application (NDA) for Ophena with the FDA in early 2010.  

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