Watson receives FDA approval for Androderm lower-dose formulations

Oct 21 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. Food and Drug Administration (FDA) approved its Androderm® (testosterone transdermal system) 2 mg and 4 mg formulation.  The new smaller size and lower-dose testosterone patch provides highly effective testosterone administration with a 20 percent reduction in the active ingredient from the original strength in a smaller patch size.  Watson plans to launch the new Androderm® formulation in November 2011 and the product will be marketed in the U.S. by the Company's Global Brands business.

Approval of the lower dose formulation was based on a trial showing 97 percent of the subjects achieved testosterone concentrations within the normal range after 28 days of daily therapy.  In the study, 94 percent of patients achieved normal testosterone levels by Day 8 with the 4 mg/day formulation with low rates of many common testosterone-related adverse events.  The recommended starting dose for the new Androderm® transdermal system is 4 mg/day, which may be increased to 6 mg/day or decreased to 2 mg/day as needed.  

Androderm® is indicated as testosterone replacement therapy in males 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.  Causes for testosterone deficiency include genetic abnormalities, side effects from certain medications, pre-existing conditions such as diabetes, and injury to the testes.  

"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," said Jed C. Kaminetsky, MD, urologist at University Urology Associates and clinical assistant professor of urology at New York University School of Medicine.  "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."

Testosterone is one of two naturally-produced male hormones, endogenous androgens, responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.  Symptoms of male hypogonadism include erectile dysfunction, decreased sexual desire, fatigue, loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis.