Phase 3 study of Ophena for treatment of dyspareunia associated with postmenopausal vaginal atrophy

QuatRx Pharmaceuticals announced positive efficacy results from the second of two patient cohorts in its second Phase 3 study for Ophena (ospemifene tablets) for the treatment of dyspareunia (sexual pain) associated with postmenopausal vulvovaginal atrophy (VVA).  A previous announcement from the same Phase 3 study focused on positive results regarding the treatment of vaginal dryness with Ophena.  This study was a randomized, double-blind, placebo-controlled trial of 919 patients with vulvovaginal atrophy conducted at 116 sites in the United States. The results announced today focused on the cohort of 605 women in the study who identified dyspareunia as their most bothersome symptom. Positive efficacy results were achieved in all four co-primary endpoints, including decrease in parabasal and superficial cells from vaginal smear, decrease in vaginal pH and improvement in the patient’s most bothersome moderate to severe symptom of dyspareunia. The results showed highly statistically significant changes from baseline to week 12 compared to placebo in all four co-primary endpoints (p<0.0001). All women were supplied with a non-hormonal vaginal lubricant to be used as needed during the treatment period and the study results demonstrated efficacy above and beyond this lubricant usage, as also observed in the first Phase 3 study.

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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