CHADDS FORD, Pa. — Endo Pharmaceuticals has obtained Food and Drug Administration clearance to market Fortesta Gel for topical use to treat men with low testosterone.
The pharmaceutical company said Wednesday that Fortesta Gel is the first approved testosterone replacement therapy gel with application to the front and inner thighs. Plans call for Endo to roll out Fortesta Gel in the United States in early 2011.
Low testosterone, also known as "Low T" and hypogonadism, affects nearly 14 million men in the United States, yet only about 1.3 million, or 9%, are currently being treated, Endo reported. Symptoms of the condition include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.
"The approval of Fortesta Gel reinforces our commitment to men’s health by providing an important new treatment option for millions of men with Low T," David Holveck, chief executive officer of Endo Pharmaceuticals, said in a statement.
Fortesta Gel is a clear, colorless and odorless testosterone gel that is applied with one finger to the front and inner thighs, not the upper body, according to Endo. The medication comes in a metered-dose pump that’s designed to deliver the correct dose per complete depression.
"Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems," stated Adrian Dobs, M.D., professor of medicine and oncology, Johns Hopkins University School of Medicine, Division of Endocrinology and Metabolism in Baltimore, and principal investigator of the Fortesta Gel Phase III clinical trial. "Fortesta Gel is an important new treatment option for men who are diagnosed with low testosterone."
