QuatRx Pharmaceuticals, a biopharmaceutical company, has completed enrollment in the company’s second pivotal Phase III clinical trial of Ophena, an advanced estrogen-free oral therapy currently in development for the treatment of vaginal symptoms associated with menopause.
Together with the previously completed first pivotal Phase III study of Ophena, the company has fully enrolled its planned pivotal Phase III studies for Ophena. A total of more than 1,700 patients were enrolled in these two pivotal studies at sites across the US.
In accordance with the study design, all enrolled patients have received their first dose of either Ophena or placebo in the second Phase III clinical trial. Due to the high level of interest from patients and physicians, the company chose to exceed its enrollment target of 750 patients.
The company expects to complete the study in late summer-2009 and these data, together with results from the first Phase III study, will complete the efficacy requirements for a new drug application filing for vaginal atrophy.
The randomized, double-blind study has enrolled over 900 postmenopausal women at 116 trial centers throughout the US. Women in the study are being treated with either a 60mg once daily oral dose of Ophena or placebo over the 12-week treatment period. All women are also being supplied with a non-hormonal vaginal lubricant to be applied as needed during the treatment period.
Robert Zerbe, CEO and president of QuatRx, said: We are pleased to have achieved this important development milestone in the development of Ophena and to have exceeded our enrollment goal in only seven months, in what we believe to be the largest vaginal atrophy study ever conducted. We believe that the high interest in this study indicates a substantial need for new therapies for the treatment of postmenopausal vaginal atrophy.