QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vagin... (ost bothersome symptom. The positive eff...)

QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy

Date:7/29/2009

ost 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(TM). The results also demonstrate that Ophena(TM) was well-tolerated. A second cohort of the study, consisting of 605 patients with the most bothersome moderate to severe vaginal atrophy symptom of dyspareunia, is fully enrolled and will report out in late summer of this year.

The latest 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). All women were supplied with a non-hormonal vaginal lubricant to be applied 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.

Phase 3 Long Term Safety Update

In January 2008, QuatRx announced positive results from its first pivotal Phase 3 trial of Ophena(TM). The Company has since completed two long term safety extensions from this first Phase 3 trial. Women who had undergone a hysterectomy were enrolled in an open label study of 60mg Ophena(TM) for an additional year of therapy. Women with an intact uterus were enrolled into an extension study where the treatment blind was maintained for a total of a year. In this study, 83% of women taking 60mg of Ophena(TM) completed the study, compared with 69% of women on placebo. The most frequently occurring treatment-emergent adverse event that was considered related to study drug was hot flush (7% in 60mg Ophena(TM) vs. 4% in placebo). Most treatment-emergent adverse events were m
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QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vagin...(ost bothersome symptom. The positive eff...),Health