Repros Submits Response To FDA Regarding Androxal(R) Indication For Treatment Of Hypogonadal Men Wishing To Preserve Fertility

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  Fertility
Article Date: 10 Feb 2010 - 0:00 PDT

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Repros Therapeutics Inc. (NasdaqCM:RPRX) announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the 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 FDA suggested it will respond to Repros' submission in a timely fashion following receipt of Repros' materials.

Repros will provide an in depth review of the outcome of the Type C meeting held with the FDA on January 25, 2010 during its BIO/CEO presentation today at 2:30 p.m. Eastern Standard Time. There will be a live video webcast of the event and subsequently archived for at least one month on the Company's website http://www.reprosrx.com under the "Events" heading on the home page. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time to ensure adequate time to download any software that may be necessary.

Source
Repros Therapeutics Inc.

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