Eli Lilly and Company and Acrux announced that the U.S. Food and Drug Administration (FDA) has approved Axiron (testosterone) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone. Safety and efficacy of Axiron in males younger than 18 years of age have not been established.
Axiron is the first testosterone topical solution approved for application via an armpit (underarm) applicator. Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands.
Although the total number of men with testosterone deficiency is unknown, it has been estimated that up to 13 million men over 45 years of age in the U.S. may have symptoms associated with low testosterone. Clinical trial data indicated that Axiron can restore blood concentration of testosterone within the normal range in most men.
“Lilly is proud to expand our focus in men’s health,” said David Ricks, president, Lilly USA. “The addition of Axiron to our product portfolio reinforces Lilly’s commitment to provide innovative treatment options for patients.”
“The FDA approval is a major milestone for Axiron and for Acrux,” said Dr. Richard Treagus, chief executive officer, Acrux. “After years of research, we are excited to partner with Lilly to provide this novel application method for men with low testosterone.”
Date: November 23, 2010
Source: Eli Lilly and Company