Repros® Therapeutics Reports Outcome of Type B Meeting with FDA Regarding Androxal® in the Treatment of Secondary Hypogonadism
09 Noviembre 2010 - 12:29PM
Business Wire
Repros Therapeutics Inc.® (NasdaqCM:RPRXD) today reported on the
outcome of a Type B meeting held with the FDA to discuss two Phase
3 protocols for the use of Androxal® in the treatment of secondary
hypogonadism in men. The FDA opined that a Phase 2B study in men
with secondary hypogonadism but naïve to testosterone treatment
would provide for a more solid data base for design of Phase 3
studies and eventual approval of such studies under an SPA. The FDA
did note “the Division agrees in general with the outline of your
program for the development of enclomiphene” (Androxal). They
further stated that if the Company moved to Phase 3 at this time it
would do so at its own risk.
The FDA accepted the notion of secondary hypogonadism associated
with aging as an appropriate population. They suggested that the
next study be conducted in men naïve to testosterone treatment or
off testosterone treatment for at least six months. They felt that
this population would exhibit a more consistent profile at
baseline. As outlined in the Company’s submitted protocols the FDA
requested that the trial consist of four arms; placebo, two doses
of Androxal and topical testosterone. At baseline the men should
exhibit morning testosterone less than 250 ng/dl. They further
noted that the endpoints should consist of total testosterone and
sperm counts at the end of study compared to baseline.
The Company agreed with the FDA comments and noted it would
analyze the previously completed ZA-003 study for the subset of men
with morning testosterone less than 250 ng/dl and submit the data.
Repros previously performed this assessment and found a
statistically significant improvement in morning testosterone and
no deterioration of follicle stimulating hormone, an important
pituitary hormone controlling spermatogenesis, in Androxal-treated
men. However, in the men on topical testosterone, 26 out of the 41
men that completed three months of dosing exhibited follicle
stimulating hormone levels below the reference limits for the
hormone, with 17 below the lower limit of detection.
The FDA also noted that 24 hour assessment of testosterone is
the preferred method for assessing response for topical
testosterone preparations. The Company noted that it had previously
conducted 3 studies in which 24 hour testosterone levels were
obtained and unlike topical testosterone, morning testosterone was
the maximum concentration observed consistent with the normal
circadian rhythm in men. The Company agreed to combine the three
studies into one analysis for FDA review.
“We are pleased with the overall outcome of the Type B meeting
with the FDA,” Joseph Podolski, President and CEO of Repros
commented. “Although the FDA did not agree with our proposal for
moving into Phase 3 trials under an SPA at this time, they clearly
stated that they are in support of our intended development program
for Androxal in treating men with secondary hypogonadism. We are
encouraged with the progress we have made with the FDA in moving
this drug candidate toward eventual commercialization. We also
believe that the data we plan to provide the FDA from our prior
studies, together with the anticipated results from this Phase 2B
study, should be sufficient to move this drug into SPA reviewed
Phase 3 trials without any additional costs or delays from our
original proposed development plan.”
Repros has an issued patent teaching the use of Androxal in
restoration of testicular function and has pending patent
applications that deal specifically with the drug’s ability to
impact glycemic control.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small
molecule drugs for major unmet medical needs that treat male and
female reproductive disorders.
Any statements that are not historical facts contained in this
release are forward-looking statements that involve risks and
uncertainties, including Repros' ability to have the partial hold
on Proellex® lifted and to determine a safe and effective dose for
Proellex, maintain its listing on the NASDAQ Capital Market, raise
needed additional capital on a timely basis in order for it to
continue to fund its operations and pursue its development
activities, and such other risks which are identified in the
Company's most recent Annual Report on Form 10-K and in any
subsequent quarterly reports on Form 10-Q. These documents are
available on request from Repros Therapeutics or at www.sec.gov.
Repros disclaims any intention or obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
For more information, please visit the Company's website at
http://www.reprosrx.com.
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