ANN ARBOR – QuatRx Pharmaceuticals Company, announced Thursday the end of the company’s long-term safety study for its menopause treatment drug, Ophena, which position the company to file a New Drug Application with the US Food and Drug Administration in early 2010.
Specially, the company said it received positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena, (ospemifene tablets), the company�??s investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA).
This second phase 3 study of Ophena was a randomized, double-blind, placebo-controlled study with 919 women with vulvovaginal atrophy. The study was conducted at 116 sites in the United States. Among 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.
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.
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