Repros Therapeutics, Inc. (RPRX)

[hiwatt1959]

Below is trial design for Allergan P3 Pearl IV which was the same Venus 2 for Esmya. Clearly they are using an "off drug interval" in their 2 course line of treatment.
We believe that the intermittent 12-week ulipristal acetate daily dose regimens (the first course to be administered at the start of a menstrual cycle, and subsequent courses to commence at the start of the second menses after the previous course) fulfill most of these criteria, as evidenced by the low side effect burden and discontinuation rate, and the high compliance with treatment. Some patients did experience pain and excessive bleeding during off-treatment periods but generally not of the same magnitude as prior to treatment. Also there was no regrowth of fibroids observed during follow-up. Thus our results suggest that intermittent ulipristal acetate is a viable and attractive long-term medical management option for patients with symptomatic fibroids. Our data are also consistent with the results of an earlier study (26) reporting that up to four intermittent treatment courses of ulipristal acetate could be successively administered to control bleeding and shrink fibroids