QuatRx Reports Positive Results From Second Phase 3 Study Of Ophena

QuatRx Pharmaceuticals (QuatRx) has reported positive efficacy results from the second of two patient cohorts in the second pivotal phase 3 study of Ophena (ospemifene tablets).

Ophena is the company’s investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA). The second phase 3 study of Ophena was a randomized, double-blind, placebo-controlled study with 919 women with vulvovaginal atrophy.

The trial, together with the recent completion of a long-term safety study for Ophena, marks the end of the company’s comprehensive phase 3 efficacy and safety program for Ophena and positions QuatRx to file a New Drug Application (NDA) with the FDA in early 2010.

Reportedly, the results showed significant changes from baseline to week 12 compared to placebo in all four co-primary endpoints. All women were supplied with a non-hormonal vaginal lubricant to be used as needed during the treatment period. The study results demonstrated efficacy above and beyond this lubricant usage, as also observed in the first phase 3 study.

The company’s planned NDA for 2010 will seek regulatory approval for Ophena, a new SERM (selective estrogen receptor modulator), for the treatment of the symptoms of postmenopausal vulvovaginal atrophy. Ophena is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause.

Robert Zerbe, CEO of QuatRx, said: “These findings provide substantial additional evidence indicating the potential of Ophena to be a first-in-class non-estrogen drug for the treatment of vaginal atrophy.

“With the completion of our second pivotal phase 3 study, we believe we have now fully confirmed the efficacy of Ophena according to the criteria established by FDA under the applicable guidance for this indication. Based on this, we are working aggressively to move forward with our NDA submission and to bring this new treatment option to the millions of women affected by vaginal atrophy who want an alternative to estrogen therapy.”