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news.Rexahn Pharmaceuticals, a biopharmaceutical company, has completed enrollment in its Phase IIa clinical trial evaluating Zoraxel for treatment of erectile dysfunction.
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The Zoraxel Phase IIa trial is a double blind, placebo-controlled, dose ranging study conducted at three US study sites in up to 40 male subjects ages 18 to 65 with erectile dysfunction (ED) for six months.
Main study endpoints for the eight-week treatment period were the sexual encounter profile and the international index of erectile function, both of which are validated surveys for assessing erectile function. Planning is underway for initiation of Phase IIb clinical studies. The company expects to have preliminary study results in March 2009.
Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three compounds being developed by Rexahn as a part of the company’s clinical stage drug pipeline.
Chang Ahn, chairman and CEO of Rexahn, said: It has been our stated goal to move our three highly-marketable compounds successfully through the clinical trial process, and the completion of patient enrollment in the Zoraxel trial represents another steady step in the right direction for Rexahn.
This milestone is especially meaningful to us, as we have long believed that our ED compound is a safer and more effective alternative to currently marketed drugs for ED.