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news.QuatRx Pharmaceuticals has reported primary endpoint results from a pivotal Phase III clinical trial of Ophena to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause.
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The study successfully met all four co-primary endpoints. Women treated with Ophena at the 60mg dose showed statistically significant improvements in vaginal dryness and dyspareunia, as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels. Ophena was generally well tolerated and demonstrated a favorable safety profile.
In the Phase III Ophena clinical study, women were asked to identify their most bothersome symptom of vaginal atrophy. The co-primary endpoints 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 improvements in the most bothersome moderate to severe vulvovaginal atrophy symptom.
The study investigated treatment with Ophena administered orally, once-daily at 30 and 60mg doses as compared to a placebo. Women were 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.
Robert Zerbe, president and CEO of QuatRx, said: “These results provide strong support for our efforts to advance Ophena through the regulatory review process. Our next Phase III trial for Ophena will begin later this year.”