Nelson Vergel
Founder, ExcelMale.com
Repros is developing Androxal[SUP]®[/SUP] , a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound.
Repros Therapeutics Inc said the U.S. health regulator sought additional studies of its testosterone replacement drug, Androxal, and recommended that a safety study of the drug be extended, delaying potential approval.
Shares of the company fell 33 percent in premarket trading.
Repros said the company's marketing approval application would be delayed to the fourth quarter of 2014, if the results of the study have to be included.
Comment: Clomiphene (Clomid) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.Clomiphene has been shown to raise testosterone in men but has not been shown to improve sexual function. The drug has been used for many years by the bodybuilding community after an anabolic steroid cycle in hopes to reset the HPG axis more quickly. Clomiphene is a generic now but the company is trying to get approval for a isomer of the molecule which may have similar qualities. An isomer can be patented even if a generic of the molecule is available. It has not been used widely as a testosterone replacement option. I doubt that the FDA will approve it unless they can show statistical significant improvement in sex drive, mood and other symptoms of hypogonadism.
Repros Therapeutics Inc said the U.S. health regulator sought additional studies of its testosterone replacement drug, Androxal, and recommended that a safety study of the drug be extended, delaying potential approval.
Shares of the company fell 33 percent in premarket trading.
Repros said the company's marketing approval application would be delayed to the fourth quarter of 2014, if the results of the study have to be included.
Comment: Clomiphene (Clomid) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.Clomiphene has been shown to raise testosterone in men but has not been shown to improve sexual function. The drug has been used for many years by the bodybuilding community after an anabolic steroid cycle in hopes to reset the HPG axis more quickly. Clomiphene is a generic now but the company is trying to get approval for a isomer of the molecule which may have similar qualities. An isomer can be patented even if a generic of the molecule is available. It has not been used widely as a testosterone replacement option. I doubt that the FDA will approve it unless they can show statistical significant improvement in sex drive, mood and other symptoms of hypogonadism.
