In the Company’s submission that reanalyzed the data from previous studies of Androxal, it also reviewed with the FDA the variability of morning testosterone levels from day to day. Over a six-month period, men on placebo moved in and out of the normal range for morning testosterone. In that submission the Company noted, “The sponsor believes this finding raises one other consideration. Given that a variety of factors can cause episodes of low testosterone, we believe starting all men on exogenous testosterone is not appropriate. Once exogenous testosterone therapy is initiated a subject would be relegated to such therapy due to the suppressive effects on pituitary responsiveness. A drug such as Androxal would allow men who exhibit episodes of low T to be treated in a fashion that does not impair pituitary responsiveness. This is particularly true for younger men. As the male ages and the testes no longer are capable of responding to pituitary stimulatory signals, exogenous preparations of testosterone would be appropriate treatments.”
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 success in its clinical trial programs, 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.