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Enrollment in DEXA study should ensure mid-2014 NDA submission
Pivotal studies recruiting on track or faster
Data project 83% of men with secondary hypogonadism will be successfully treated
No testosterone levels achieved beyond the normal range
Excellent benefit-risk ratio
THE WOODLANDS, Texas, Jan. 7, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX) today provided a clinical update of its Androxal
® Phase 3 program.
1-Year DEXA Study
Critical path analysis showed that the DEXA study was key to an NDA submission. The Company is pleased to announce that the one year DEXA study is fully enrolled 3 months ahead of schedule. This key event should ensure the submission of the Androxal NDA by mid-2014. The Company plans to continue enrollment into the study to ensure that the FDA mandated long term safety requirements for a minimum exposure of 800 subjects for 6 months are met.
Pivotal Studies ZA-301 and ZA-302
ZA-301 has been fully enrolled for several weeks now with 8% of the subjects having completed the study. 3% of the subjects have dropped out before the first visit post the start of dosing. 146 subjects (randomized 3:1 active:placebo) have reached the 6 week visit at which time up-titration was allowed. 35% of the men in this blinded study have up-titrated. This is consistent with the fact that 25% of the subjects are on placebo and approximately 80% of men are projected to achieve normal testosterone levels on the 12.5 mg dose.
There have been no SAE's resulting in withdrawal from the study.
Though only a few sperm counts have been analyzed, men that achieve higher testosterone levels appear to exhibit increased sperm concentrations. This would be consistent with Androxal's action, which results in increased secretions of pituitary hormones that drive testicular function.