October 21, 2011 — The US Food and Drug Administration (FDA) has approved 2 lower-dose formulations of Watson Pharmaceutical's Androderm (testosterone transdermal system), the company announced today.
The patches are now available in dosing strengths of 2 mg and 4 mg. It's already available in 2.5-mg and 5-mg strengths.
The company says approval of the lower-dose formulation is based on a trial showing that 97% of the patients achieved testosterone concentrations within the normal range after 28 days of daily therapy; 94% of patients achieved normal testosterone levels by day 8 with the 4-mg/d formulation, with low rates of common testosterone-related side effects.
Androderm is indicated as testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. Low testosterone affects an estimated 13.8 million men in the United States; its prevalence increases with age.
In a statement from Watson Pharmaceuticals, Jed C. Kaminetsky, MD, urologist at University Urology Associates and clinical assistant professor of urology at New York University School of Medicine, said, "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 underdiagnosed and undertreated condition."
"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," Dr. Kaminetsky added.
Watson plans to launch the new lower-dose patches in November 2011, and the product will be marketed in the United States by the company's Global Brands business.
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Cite this: FDA Okays 2 Lower-Strength Testosterone Patches - Medscape - Oct 21, 2011.