Repros Therapeutics Inc.
) recently provided an update on its phase III program, Androxal
indicated for the treatment of secondary hypogonadism.
The company has started randomizing subjects in the first of the
two pivotal phase III studies, ZA-301, at different clinical sites
in the US. The second phase III study, ZA-302 is expected to start
patient enrollment after the completion of patient enrollment in
We note that the two phase III studies are being conducted under
the Food and Drug Administration's (FDA) Special Protocol
Assessment (SPA) program. In July 2012, the company had announced
that it has reached an agreement with the FDA regarding the phase
III study design for Androxal.
Repros Therapeutics expects to provide an update from the first
pivotal study in the fourth quarter of 2012. The company believes
it will be able to report results from the study in the second
quarter of 2013.
The company is also conducting a six-month open label study,
ZA-300 (n~500), to build a safety database as required by the US
The study has enrolled of 158 men till date and 62 men completed
6 weeks of treatment with the 12.5 mg dose.
Finally, Repros Therapeutics has also started enrolling patients
for the one-year study DEXA (ZA-3030), which will evaluate the
effects of Androxal on bone mineral density.
The company expects to file a New Drug Application (NDA) for
Androxal in the first half of 2014.
Repros Therapeutics believes its current cash position will
support the development of Androxal and studies being conducted
with Proellex. The company expects the funds to be sufficient up to
We note currently approved treatments include
Endo Health Solution Inc.
), Fortesta and
Auxilium Pharmaceuticals, Inc.
We currently have an Underperform recommendation on Repros
Therapeutics. The stock carries a Zacks #4 Rank ('Sell' rating) in
the short run.
AUXILIUM PHARMA (AUXL): Free Stock Analysis
ENDO PHARMACEUT (ENDP): Free Stock Analysis
REPROS THERAPEU (RPRX): Free Stock Analysis
To read this article on Zacks.com click here.