Repros Therapeutics Inc announced that the company, as requested by the US FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the US FDA’s Division of Reproductive and Urologic Products for the use of Androxal in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state.
The company also provided a literature review supporting the company’s belief that administration of exogenous testosterone at doses resulting in morning testosterone levels within the normal range render a significant number of men oligospermic (sperm counts less than the generally accepted level of male fertility). The company also submitted the final clinical study report investigating the fertility impact of Androxal compared to a topical testosterone in men previously treated with testosterone for hypogonadism. Previously, the company noted that the US FDA suggested it will respond to Repros’ submission in a timely fashion following receipt of Repros’ materials.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.