Repros Receives Guidance From FDA Regarding Continued Development Of Androxal(R) In Hypogonadal Men

Repros Therapeutics Inc. (NasdaqCM:RPRX) announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting was to gain a better understanding of the FDA’s position regarding the use of Repros’ oral Androxal® product in the treatment of men with secondary hypogonadism wishing to preserve their fertility. The Company’s data supports the notion that the negative feedback of exogenous testosterone administered by any route suppresses the hypothalamic-pituitary axis and hence spermatogenesis.

The discussion with the FDA focused on two issues. Firstly, the FDA requested that the Company propose a label that better defines the population of individuals for whom Repros believes will benefit from the use of Androxal. Secondly, the FDA requested the Company conduct a literature review of the incidence of infertility associated with the use of exogenous testosterone as supportive of the Company’s data. The FDA requested that the Company provide such information and if the FDA finds the submission appropriate no additional clarifying meeting regarding the indication for Androxal may be required. During the course of the meeting Repros noted that if the FDA concurred with the indication proposed by the Company, Repros would like to request a special protocol assessment (SPA). The FDA responded that the issues noted above should be resolved first before undertaking a protocol review.

On the call for Repros were Dr. Jean Fourcroy MD, Repros Board member and former medical officer at the division of Reproductive and Urologic Products at the FDA (CDER), Dr. Andre T. Guay MD, Center for Sexual Function (Endocrinology), Lahey Clinic (Dr. Guay has authored numerous publications on the use of Clomid in the treatment of secondary hypogonadism), Dr. Jed Kaminetsky MD, Department of Urology, New York University Medical Center, a practicing urologist in the metropolitan area of New York focusing on reproductive disorders and a principal investigator in a Repros study, Dr. Ronald Wiehle, VP of R&D at Repros and Joseph Podolski, President and CEO. Repros and its consultants believe that they can clearly define the intended patient population who will benefit from the use of Androxal and provide the FDA with existing scientific citations that support the notion that exogenous testosterone administration impairs male fertility.

In a study previously completed by Repros, blinded Androxal 12.5mg and 25mg were compared to open label Androgel used per manufacturers recommendations and blinded placebo in hypogonadal men that met the criteria of secondary hypogonadism (T

source : mnt.to

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