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New formulations of testosterone transdermal system approved by FDA
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The FDA has approved 2-mg and 4-mg formulations of a testosterone transdermal system for treatment of men with testosterone deficiency. The new formulations represent a 20% decrease from the product’s original strength and are offered in a smaller patch size.
According to a press release, the FDA based its approval on a trial demonstrating that 97% of participants achieved testosterone concentrations within the normal range after 28 days of therapy with the testosterone transdermal system (Androderm, Watson Pharmaceuticals). Moreover, 94% achieved normal levels after 8 days with the 4-mg/day formulation. The rates of common adverse events associated with testosterone were also low. The manufacturer recommends initiating therapy with the 4-mg/day dose and, if necessary, increasing to 6 mg/day or decreasing to 2 mg/day.
“The approval of the new low-dose testosterone patch offers millions of men a reliable and convenient transdermal option for what continues to be an under-diagnosed and undertreated condition,” Jed C. Kaminetsky, MD, urologist at University Urology Associated and clinical assistant professor of urology at New York University School of Medicine, said in the release. “The new Androderm formulation effectively treats symptoms of male hypogonadism, which include decreased sexual desire, fatigue and mood depression. In addition, the patch helps minimize the risk that the testosterone may be transferred from patients to children or women, unlike testosterone gel preparations.”
The manufacturer said the patch will be available in its new formulations in November.
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