QuatRx Pharmaceuticals Co. said results from a pivotal Phase III study of Ophena (ospemifene), to treat postmenopausal women with vulvovaginal atrophy showed the compound met all of its co-primary endpoints.
The trial was to evaluate the efficacy of Ophena vs. placebo over a 12-week treatment period in 826 women with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
The 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 the most bothersome moderate to severe vulvovaginal atrophy symptom, consistent with FDA guidance.
Top-line data indicated that the study achieved a statistically significant result in each endpoint and that Ophena was well tolerated.
The study investigated two doses, 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 nonhormonal vaginal lubricant to be applied as needed during the treatment period.
Ann Arbor, Mich.-based QuatRx said complete data from the study are being analyzed and will be submitted for presentation at an upcoming scientific meeting and for a journal publication.
Ophena is being developed as the first nonestrogen prescription treatment alternative for vulvovaginal atrophy. QuatRx gained rights to it in its May 2005 acquisition of Finnish firm Hormos Medical Ltd. (See BioWorld Today, May 17, 2005.)