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UPDATE 1-Repros to meet FDA to discuss testosterone drug trial
* To meet FDA on Nov. 8 to discuss efficacy protocols
* Repros asks FDA to consider protocols under SPA
* Expects to start late-stage trials in early 2010
Sept 30 (Reuters) - Repros Therapeutics Inc (RPRX.O) said it will meet the U.S. health regulator on Nov. 8 to review the efficacy protocols of the late-stage trials of Androxal, its experimental drug to treat testosterone deficiency in men.
The company expects to start two studies, designed to show that only Androxal normalizes both testosterone and sperm concentrations as compared to topical testosterone or a dummy drug, in early 2011.
Repros has also asked the U.S. Food and Drug Administration to consider the trials under a Special Protocol Assessment (SPA), it said in a statement on Thursday.
An SPA provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing application submission.
Androxal is being developed for the treatment of secondary hypogonadism, or a defect of the gonads that results in the underproduction of testosterone.
In 2004, the FDA indicated to the company that testosterone as an endpoint was not suitable for a drug such as Androxal and that it would need to determine an additional clinically relevant outcome.
Shares of Woodlands, Texas-based Repro have gained 8 percent since last month when the FDA accepted the company's proposal to conduct the late-stage trials. They closed at 39 cents Wednesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Aradhana Aravindan)
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