Reuters: Regulatory News: Repros Therapeutics gets FDA go-ahead on testosterone drug study

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Repros Therapeutics gets FDA go-ahead on testosterone drug study Feb 21st 2013, 13:57 Thu Feb 21, 2013 8:57am EST Feb 21 (Reuters) - Repros Therapeutics Inc said U.S. health regulators agreed with the company's plan to proceed with analyzing data from a late-stage study of its experimental testosterone drug Androxal, putting the company on track to report trial data in the third quarter. Repros shares were up 30 percent at $13.22 before the bell on Thursday. The company last month pushed back the expected date to report data from the first of two late-stage studies after it found that the patient population at a site where the drug was being tested was markedly different from 16 other sites. Repros proposed to the U.S. Food and Drug Administration that patients from that site be removed from the study and be replaced by patients at other sites who were enrolled for the second late-stage study. Repros said on Thursday that the FDA mostly agreed with its plan, but asked the company to evaluate data from the studies with and without patients from the site with the differing characteristics. Barring this, the special protocol assessment under which Repros is developing Androxal remains intact, allaying concerns that the results from the studies would be delayed further. The company's shares had fallen 45 percent since it proposed the changes to the study in late January. Repros said at the time that it expected to report data from the first study in the third quarter and subsequently file for U.S. approval of the drug in mid-2014. A special protocol assessment provides a company with a written agreement from the FDA that the design of the study and analysis of the data are adequate to support a marketing application. Androxal is one of two Repros products in development. The other, Proellex, is being tested to treat uterine fibroids - noncancerous tumors that develop in the womb. Androxal is expected to compete with AbbVie Inc's Androgel, Auxilium Pharmaceuticals Inc's Testim and Eli Lilly and Co's Axiron, all of which are already on the market. Link this Share this Digg this Email Reprints

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