Published on February 8, 2010 at 7:11 AM
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the
Company, as requested by the FDA during the Type C meeting held on
January 25, 2010, has sent a revised indication statement to the FDA’s
Division of Reproductive and Urologic Products for the use of Androxal®
in the treatment of men wishing to preserve fertility while being
treated for their hypogonadal state. The Company also provided a
literature review supporting the Company’s belief that administration of
exogenous testosterone at doses resulting in morning testosterone levels
within the normal range render a significant number of men oligospermic
(sperm counts less than the generally accepted level of male fertility).
The Company also submitted the final clinical study report investigating
the fertility impact of Androxal compared to a topical testosterone in
men previously treated with testosterone for hypogonadism. Previously,
the Company noted that the FDA suggested it will respond to Repros’
submission in a timely fashion following receipt of Repros’ materials.
SOURCE Repros Therapeutics Inc.