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news.QuatRx Pharmaceuticals has reported positive results from a pivotal Phase III study of Ophena to treat postmenopausal women with vulvovaginal atrophy, a common condition associated with menopause.
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Top line data show that the multi-center, double-blind, placebo-controlled study successfully met all of its co-primary endpoints and that Ophena was well tolerated. The study was conducted in 80 US centers and involved more than 800 women.
This pivotal Phase III study was designed to evaluate the efficacy of Ophena versus placebo over a 12-week treatment period in women with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
The primary endpoints for the Phase III Ophena clinical trial were defined as the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and the most bothersome moderate to severe vulvovaginal atrophy symptom, consistent with the appropriate FDA guidance.
The study investigated two doses of Ophena versus placebo, administered once daily, with patients randomized (1:1:1) into a double-blind 12-week treatment period with a four-week follow-up or the opportunity to continue in a long-term safety extension study. All subjects were supplied with a non-hormonal vaginal lubricant to be applied as needed during the 12- week treatment period.
Ophena is a novel selective estrogen receptor modulator (SERM) that is being studied as a treatment for women with postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy.
Robert Zerbe, CEO and president of QuatRx, said: “We believe Ophena could provide the first non- estrogen prescription treatment alternative for PVS. QuatRx is well positioned to continue with our plans to advance this exciting product to commercialization, pending regulatory review and approval.”