Repros Therapeutics Analyst Brief Report; Androxal(R) Achieves Superiority in Top Line Analysis by Small Cap Street …

Recommended by Dr. Michael White, Updated on October 31st, 2020

NEW YORK, Sept. 29, 2014 /PRNewswire-USNewswire/ --Androxal(R) Second Pivotal Study from Repros Therapeutics Inc. (NASDAQ: RPRX) a development stage biopharmaceutical company, achieves superiority in top line analysis for both co-primary endpoints compared to marketed topical gel in the treatment of secondary hypogonadism.

However, the conclusions of the FDA Advisory Panel that met on Wednesday, September 17, 2014, to discuss the appropriate population suited to testosterone replacement therapy (TRT), were not directly related to Androxal(R), since Androxal(R) is not a form of testosterone. The FDA panelists voted to recommend that testosterone replacement class label should be changed, narrowing the treatment option to those with indications such as testes, pituitary or hypothalamus impairment, and excluding age-related hypogonadism, which the panel considered as a normal sign of aging.

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Repros Therapeutics Analyst Brief Report; Androxal(R) Achieves Superiority in Top Line Analysis by Small Cap Street ...

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