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Androxal Achieves Superiority In Top Line Analysis For Both Co-Primary Endpoints And Various Secondary Endpoints

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  • 23.8% of Topical T subjects below 10 million sperm/mL at end of study versus 2.3% and 2.4% respectively for Androxal® and placebo ITT (Androxal® vs. Topical T, p = 0.0031)
  • 33.3% reduction from baseline sperm concentration for Topical T subjects versus 5.9% increase for Androxal® subjects ITT (p=0.0004)
  • 33.3% responder rate for Topical T versus 65.9% rate for Androxal® ITT (p = 0.0025)
  • 16 week treatment with Topical T subsequently suppresses endogenous production of T on cessation of dosing versus baseline T levels (230 ng/dL baseline versus 183 ng/dL one week after dosing stops, p =0.0004)
  • Androxal® maintains normal levels of endogenous T one week after dosing cessation (370.9 ng/dL, comparison to Topical T p < 0.0001)

Repros Therapeutics Inc.® (Nasdaq: RPRX) today reported top line results for the first of two identical pivotal studies comparing Androxal® to a leading FDA approved topical gel (Androgel® 1.62) and placebo. In this study, ZA-305, Androxal® exhibited superiority in several assessments, particularly the two co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24 hour average testosterone in the normal range with associated average sperm concentration ≥ 10 million/mL.

Multiple secondary endpoints also showed statistically significant differences between the Androxal® and T gel groups. These include: change in the important pituitary signaling hormones LH and FSH; percent of subjects that become severely oligospermic (< 10 million sperm/mL); induction of hormone dependence via assessment of morning testosterone levels comparing baseline to one week after the end of dosing; and impact on testicular size at the end of the dosing period.

Posted-In: News FDA Press Releases

 

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