Feb 21 Repros Therapeutics Inc said
U.S. health regulators agreed with the company's plan to proceed
with analyzing data from a late-stage study of its experimental
testosterone drug Androxal, putting the company on track to
report trial data in the third quarter.
Repros shares were up 30 percent at $13.22 before the bell
The company last month pushed back the expected date to
report data from the first of two late-stage studies after it
found that the patient population at a site where the drug was
being tested was markedly different from 16 other sites.
Repros proposed to the U.S. Food and Drug Administration
that patients from that site be removed from the study and be
replaced by patients at other sites who were enrolled for the
second late-stage study.
Repros said on Thursday that the FDA mostly agreed with its
plan, but asked the company to evaluate data from the studies
with and without patients from the site with the differing
Barring this, the special protocol assessment under which
Repros is developing Androxal remains intact, allaying concerns
that the results from the studies would be delayed further.
The company's shares had fallen 45 percent since it proposed
the changes to the study in late January.
Repros said at the time that it expected to report data from
the first study in the third quarter and subsequently file for
U.S. approval of the drug in mid-2014.
A special protocol assessment provides a company with a
written agreement from the FDA that the design of the study and
analysis of the data are adequate to support a marketing
Androxal is one of two Repros products in development. The
other, Proellex, is being tested to treat uterine fibroids -
noncancerous tumors that develop in the womb.
Androxal is expected to compete with AbbVie Inc's
Androgel, Auxilium Pharmaceuticals Inc's Testim and Eli
Lilly and Co's Axiron, all of which are already on the