QuatRx has reported the positive top-line efficacy results from the first of two patient cohorts in its second pivotal phase 3 trial of the investigational compound, Ophena (ospemifene tablets). It is intended for the treatment of postmenopausal vulvovaginal atrophy (VVA).
Reportedly, this second Phase 3 study of Ophena is a randomized, double-blind, placebo-controlled trial of 919 patients with vulvovaginal atrophy. Patients were stratified into two cohorts based on their most bothersome moderate-to-severe vaginal atrophy symptom – either vaginal dryness or dyspareunia.
The company has provided the results of 314 patients from this study identifying vaginal dryness as their most bothersome symptom. The positive efficacy results in this cohort, achieved in all four co-primary endpoints, confirmed the results seen in the first pivotal phase 3 trial of Ophena, said the company.
The latest results showed significant changes from baseline to week 12, as 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, and improvements in the most bothersome symptom of vaginal dryness.
Robert Zerbe, CEO of QuatRx, said: We are delighted with the progress in our Phase 3 program of Ophena, which provides further evidence of the potential of Ophena as a first-in-class non-estrogen drug for the treatment of vaginal atrophy, a highly prevalent and symptomatic condition. These new efficacy data confirm results seen in our first phase 3 pivotal study and are an important milestone towards our planned NDA submission.