The Company recently submitted to the FDA a new IND for Androxal® for the treatment of Type II diabetes in men experiencing secondary hypogonadism. The potential for this indication was first exhibited in a retrospective analysis of data obtained from men exhibiting elevated fasting glucose levels during a previously conducted study of Androxal in men with low testosterone due to a hypothalamic-pituitary defect commonly known as secondary hypogonadism. Androxal exhibited a positive impact (reduction) of fasting glucose levels while neither testosterone nor placebo had effects to a similar degree. Repros is presently awaiting an FDA response. Additionally the Company has submitted a briefing package to the FDA regarding the impact of Androxal on sperm counts in men undergoing treatment for low testosterone with the goal of developing Androxal for the treatment of secondary hypogonadism in men wishing to preserve fertility during treatment for their hypogonadal state. The Company expects to interact with the FDA regarding both filings later this month.
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