In the briefing package, submitted along with the protocols, the Company also presented data to support both 12.5 and 25 mg doses as suitable for Phase III testing. In September of 2004 the Company held an “end of Phase II” meeting with the FDA during which Repros presented data supporting the selection of the two doses for a study designed to assess the ability of Androxal to normalize morning testosterone in men with secondary hypogonadism. The FDA took no issue with the dose selection but opined that testosterone as an endpoint was not suitable for a drug such as Androxal and that the Company would need to determine an additional clinically relevant outcome. Male fertility is clinically relevant. In general, men with secondary hypogonadism are fertile. It is the treatment with exogenous testosterone that induces an infertile state due to suppression of important reproduction related pituitary hormones. Therefore, in the case of Androxal, dose selection is based on the ability of the oral drug to normalize testosterone.As part of the meeting the Company has asked if the Agency will be willing to review the two pivotal protocols under a Special Protocol Assessment (SPA). The Company expects the FDA will likely request modifications to the two protocols before and if agreeing to SPA review. It should be noted that even though Androxal may be proceeding to pivotal Phase III studies, the FDA will be reviewing the drug as a New Chemical Entity and as such Repros will be required to conduct large open label safety studies (100 subjects for a year and 300-600 subjects for six months) as well as special population and drug-drug interaction studies amongst others before a new drug application can be submitted. Over 50 men have taken Androxal for over a year and over 100 men have been administered the drug for longer than 6 months. In all previous studies Androxal has been generally well tolerated.
Repros expects to commence the Phase III studies early in 2011 and, depending on the rate of recruitment, to have reportable data from one of the studies near the end of that year. The Company is presently exploring partnering and various financing options to fund the Androxal program.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 the partial hold on Proellex ® lifted and to determine a safe and effective dose for Proellex, maintain its listing on the NASDAQ Capital Market, 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