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Low-volume testosterone formulation approved for men
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Abbott received FDA approval for a new, low-volume testosterone formulation to treat low testosterone in men.
AndroGel 1.62% is a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared with AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses, according to Abbott.
“Low testosterone is a real concern for many men and it is important that men exhibiting signs and symptoms talk to their doctor about appropriate testing and treatment,” Natan Bar-Chama, MD, director of Male Reproductive Medicine and Surgery, Mount Sinai Hospital, N.Y., said in a press release. “AndroGel 1.62% is an important new option that was shown in a clinical trial to restore and maintain testosterone levels in men for up to 1 year.”
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In the randomized, double blind, controlled study, 82% of 274 hypogonadal men randomly assigned to AndroGel 1.62% or placebo achieved a normal average testosterone level (300 ng/dL to 1,000 ng/dL) at day 112. The average testosterone level achieved was 561 ng/dL. In an open-label, active-treatment maintenance period of the study, 78% of 191 men who agreed to continue in the study achieved an average testosterone level in the normal range at day 364.
The most common adverse effects reported with use of AndroGel 1.62% are increased prostate-specific antigen, mood swings, high blood pressure, increased red blood cell count and skin irritation.
Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable.
AndroGel 1.62% is expected to be available to patients in the second quarter of 2011.
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