Repros Therapeutics Inc.
) 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
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
Auxilium Pharmaceuticals Inc.
) Testim and
Eli Lilly and Company
While Repros carries a Zacks Rank #3 (Hold), Eli Lily carries
a Zacks Rank #2 (Buy).
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