Repros Therapeutics Inc.
) announced that it has received additional guidance from the FDA
related to its secondary hypogonadism candidate, Androxal. The FDA
suggested three co-primary endpoints for the two ongoing phase III
studies - ZA-304 and ZA-305 - on Androxal.
The two identical, 17-week, double-blind ZA-304 and ZA-305 studies
(n = 120 each) will compare the safety and efficacy of Androxal
with a testosterone replacement therapy (topical gel) and placebo
in restoring and maintaining testicular function.
The primary endpoints proposed by the FDA were comparing change in
sperm concentration in patients receiving Androxal as compared to
patients on the leading testosterone replacement therapy in the
U.S. and the proportion of men obtaining a testosterone in the
normal range. The FDA also recommended comparing the percentage of
men that exhibit sperm ≥ 10 million/mL and testosterone in the
normal range using Androxal, testosterone gel and placebo at the
end of 16 weeks of dosing.
Repros is modifying the primary endpoints and statistical analysis
plan for ZA-304 and ZA-305 to incorporate the suggestions made by
the FDA. However, this will not affect the schedule for study
completion. Repros expects to submit a new drug application (NDA)
to the FDA for Androxal for the secondary hypogonadism indication
by the end of this year.
Currently prescribed therapies for secondary hypogonadism include
Repros currently carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the health care sector include
BioMarin Pharmaceutical Inc.
Biogen Idec Inc.
), each carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
BIOMARIN PHARMA (BMRN): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
REPROS THERAPEU (RPRX): Free Stock Analysis
ABBVIE INC (ABBV): Free Stock Analysis Report
To read this article on Zacks.com click here.