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Repros reaches agreement with FDA for registration program of investigational secondary hypogonadism treatment

Thursday, May 10 2012 | Comments
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The Food and Drug Administration and Repros Therapeutics Inc. agreed on the registration requirements for Androxal (enclomiphene citrate), an oral therapy Repros is developing as a treatment for secondary hypogonadism.

A key discussion point in the meeting between Repros and the regulatory agency was the overall required safety database. The FDA said that unless unexpected safety issues arise, safety data for 100 individuals exposed to Androxal for one year and 800 individuals exposed for six months would be adequate. Thus far, Repros has data for approximately 70 individuals for one year and 150 individuals for six months. The company said Androxal has been well-tolerated.

The FDA also provided guidance on inclusion criteria and endpoints for two identical Phase III trials, each of which will include 152 men and have a duration of three months. Men enrolled into the study should exhibit normal sperm concentrations and total testosterone levels of less than 300 ng/dL, Repros added.

The co-primary endpoints of the trials are to be at least 75 percent of the participants achieving a 24-hour average testosterone level within the normal range and less than a 50 percent reduction in sperm counts from baseline relative to placebo.

The FDA noted that Repros' requested titration from a 12.5 mg dose to a 25 mg dose based on testosterone levels during the trial was acceptable. Repros believes that 60 percent of the men will respond adequately to the 12.5 mg dose and most of the remaining 40 percent will respond to the increased dosage.

Consistent with the drug's proposed mechanism of action, the FDA recommended that all studies be conducted in overweight men aged younger than 60 years. The agency further indicated that there was no requirement for a comparator against approved topical products, but said a one-year dual-energy X-ray absorptiometry (DEXA) study should be conducted to ensure that treatment with Androxal does not promote bone loss.

The open-label safety studies and the DEXA study will begin as soon as the Institutional Review Boards can be modified, according to Repros.

Shares of Repros closed at $5.50, up $1.32, or 31.6 percent, in heavy volume on the Nasdaq.

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