TheraTech Inc. announced Wednesday that it received a U.S.patent, No. 5,152,997, covering "method and device" foradministering testosterone across non-scrotal skin attherapeutically effective levels.
The patch, in advanced Phase III clinical trials for thetreatment of testosterone deficiency, also known ashypogonadism, in men between the ages of 18 and 65,represents a new and efficient approach to administering themale hormone.
"The patch is successfully providing normal hormone levelsthat mimic the natural rhythms of healthy men," said NormanMazer, director of clinical research for TheraTech(NASDAQ:THRT) of Salt Lake City.
The current method of treatment -- administration of thehormone by injection every three weeks -- is painful andcauses mood swings due to the high hormone level in the bodyin the first post-injection week, a leveling-out in the secondweek, and depressed moods in the third week as thetestosterone level slips prior to the next injection, according toDinesh Patel, TheraTech's president and chief executive officer.
TheraTech's patch must be renewed daily, but can be appliedacross normal skin on any part of the body. Alza Corp. of PaloAlto, Calif., also has a testosterone patch in development, but itcan only be applied to the scrotum, which is 40 times morepermeable than other parts of the body, Patel told BioWorld.
Although hypogonadism results in sexual and fertilityproblems, and chronic fatigue in a range of age groups,TheraTech sees the market for the patch expanding primarilyin the elderly male population.
"The elderly represent a major segment of the market andgrowth potential for the patch," Patel said.
He expects the product to enter the market by 1995 or 1996and predicted that its market potential will be $200 million infive years. Patel said the patches will probably cost between $2and $3 each.
In studies at two U.S. sites and one in Sweden, more than 50patients are being tested with TheraTech's testosteronetransdermal patch, which has been well-tolerated by mostpatients and has produced subjective improvements in thepatients' sexual function and vitality, according to Mazer.
-- Michelle Slade Associate Editor
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