TheraTech Inc. announced Monday that it has filedinvestigational new drug applications for its TheraDerm-MTXprogestin matrix patch and for an estradiol/progestincombination matrix patch.
The Salt Lake City company said it is seeking approval for thepatches for the treatment of post-menopausal symptoms andosteoporosis "while reducing the risk of endometrialhyperplasia associated with administration of unopposedestrogen."
Phase I trials will study the pharmacokinetics andmetabolization of progestin and estradiol in combination. Thestudy of post-menopausal women will also assess the skintolerability of patches.
The company estimated that there are currently 24 millionpost-menopausal women in the U.S., a number that is growing.TheraTech (NASDAQ:THRT) said it is discussing marketingagreements for its estradiol, progestin, and estradiol/progestincombination products with "several potential partners." --KarlThiel
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