Repros Therapeutics (RPRX) Modifies Pivotal Androxal Protocol
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Repros Therapeutics Inc. (Nasdaq: RPRX) has modified the pivotal protocol following additional FDA input post the May 9th meeting.
The revision included additional secondary endpoints specifying the number of men in the study that exhibit a single time point of testosterone concentration greater than 1500, 1800 and 2500 ng/dL. It is common to experience such high excursions for approved topical products. No subject in an Androxal study has ever exhibited a concentration greater than 1500 ng/dL and the maximum levels achieved are approximately 1100 ng/dL. This level occurs rarely and only in men administered the higher (25 mg) dose. The pivotal studies are designed to titrate men to greater than 450 ng/dL by first starting on the 12.5 mg dose. The Company believes 60% of men will achieve the 450 ng/dL up-titration threshold on the 12.5 mg dose resulting in 40% of men up-titrating to the 25 mg dose.
The difference in Androxal response as compared to the topical products is related to the mechanism of action of the Repros drug. Androxal® stimulates endogenous production of testosterone. Normal maximum testosterone production can reach a concentration of around 1040 ng/dL.
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The revision included additional secondary endpoints specifying the number of men in the study that exhibit a single time point of testosterone concentration greater than 1500, 1800 and 2500 ng/dL. It is common to experience such high excursions for approved topical products. No subject in an Androxal study has ever exhibited a concentration greater than 1500 ng/dL and the maximum levels achieved are approximately 1100 ng/dL. This level occurs rarely and only in men administered the higher (25 mg) dose. The pivotal studies are designed to titrate men to greater than 450 ng/dL by first starting on the 12.5 mg dose. The Company believes 60% of men will achieve the 450 ng/dL up-titration threshold on the 12.5 mg dose resulting in 40% of men up-titrating to the 25 mg dose.
The difference in Androxal response as compared to the topical products is related to the mechanism of action of the Repros drug. Androxal® stimulates endogenous production of testosterone. Normal maximum testosterone production can reach a concentration of around 1040 ng/dL.
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