Repros Therapeutics
Inc.^® RPRX today provided a clinical update of its Androxal^® Phase
3 program following receipt of written guidance from the FDA.
The FDA has informed Repros to proceed with the analysis of ZA-301 as
previously planned, and that data should be evaluated both with and without
patients from the high enrolling site where the patients' baseline
characteristics appeared different from other sites in the study.
Additionally, the FDA accepted Repros' plan regarding study ZA-302 to enroll
additional patients. They also noted that Repros should revise the statistical
analysis plan and sample size to reflect increased enrollment. Study ZA-302
will also be analyzed with and without patients from the high enrolling site
where the patients' baseline characteristics appeared different from other
sites in the study.
Per the guidance from the FDA, the Special Protocol Assessment (SPA) will
remain intact with the revised trial parameters outlined above.
Top line data from study ZA-301 will be reported when available, as per the
Company's guidance given at the beginning of the year.
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