Company to seek approval of oral testosterone undecanoate in the United States

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Nelson Vergel

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This company is seeking approval of a product already available in Canada as an oral agent to increase testosterone (testosterone undecanoate, the same active agent that Aveed or Nebido contains). This product needs to be taken more than once a day.


Clarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone replacement therapy in men with hypogonadism. Each trial differed in design, dose-titration algorithm, and duration. Each demonstrated T replacement, and with the revised dose-titration algorithm, the maximum serum T concentration was comparable to other T replacement therapies. The agent met the efficacy endpoint in both studies, said Clarus Therapeutics CEO Robert E. Dudley, PhD, in a press release. The studies were presented at the International Congress of Endocrinology and the Endocrine Society’s Annual Meeting and Expo in Chicago.- See more at: http://urologytimes.modernmedicine....-endpoint-phase-iii-stud#sthash.oztUUa4e.dpuf
 
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