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Repros Therapeutics Inc. (RPRX - Snapshot Report) recently announced that results from the first pivotal study (ZA-301) of Androxal will be declared in the third quarter of 2013 instead of the second quarter. The candidate is being evaluated for the treatment of secondary hypogonadism.
In this study, the patient population of one of the sites which had enrolled 40 subjects was found to be different from the other 16 sites where baseline sperm count was concerned. Thus, Repros considered it wise to remove this site from the study and replace the subjects with those enrolled at other sites.
The Androxal phase III program includes two identical pivotal phase III studies, ZA-301 and ZA-302. Enrollment for ZA-302 is expected to be completed by the first quarter of 2013. The shortfall of subjects in ZA-301 would be made up by moving enrolled subjects from the ZA-302 study.
The company still expects to file a New Drug Application (NDA) for Androxal by mid-2014.
Meanwhile, earlier this year, the company announced that it has completed the enrollment process for the one-year study, DEXA (ZA-303), evaluating the effects of Androxal on bone mineral density.
The delay in the company’s plans for reporting ZA-301 results is disappointing. We note that the market for the treatment of secondary hypogonadism is already crowded given the presence of drugs like AbbVie Inc.’s (ABBV - Snapshot Report) Androgel, Auxilium Pharmaceuticals Inc.’s (AUXL - Analyst Report) Testim and Eli Lilly and Company’s (LLY - Analyst Report) Axiron.
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