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Androxal meets both co-primary endpoints in second pivotal study ZA-302
Testosterone normalized in 81% of patients
No deleterious effects on sperm function
No excursions above normal in 24 hour average testosterone
Androxal is generally well tolerated in 6 month safety study ZA-300
No dose dependent adverse events
Adverse event profile similar or superior to other approved testosterone therapies with over 90% of safety database collected
NDA submission on track
THE WOODLANDS, Texas, Sept. 16, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX) today reported topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal
® in the treatment of men with secondary hypogonadism. Secondary hypogonadism is the largest subset of hypogonadal men accounting for greater than 85% of the reported cases. Recent scientific publications, confirmed by Company experience, suggest obesity is the single greatest cause for hypogonadism. Subjects in all ongoing Androxal studies were required to exhibit morning testosterone (T) levels of <300 ng/dL on two separate consecutive mornings, be under 60 years of age and have a BMI over 25.
All men started at the lower 12.5 mg dose but up-titrated at any time during the study if their morning testosterone was < 450 ng/dL in the 6 month study and < 300 ng/dL in the efficacy study. The lower up-titration threshold was dictated by the FDA for the efficacy study. The Company believes a level of 450 ng/dL or higher will confer the desired clinical benefits of testosterone, including metabolic and quality of life improvements.