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11/24/2010 6:33:21 AM
INDIANAPOLIS, Ind. and MELBOURNE, Australia, Nov. 23, 2010 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:LLY - News) and Acrux (ASX:ACR.ax - News) 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.
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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.(1) Clinical trial data indicated that Axiron can restore blood concentration of testosterone within the normal range in most men.(2)
"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."
About Testosterone Deficiency
Testosterone deficiency is a clinical condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone secretion and testosterone production.(3) Testosterone deficiency also may be known as hypogonadism or low testosterone. Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.(2)
About the Axiron Phase III Study
The data submission package for Axiron included findings from a Phase III multi-center, open label, 120-day clinical study which demonstrated that 84 percent of men who completed the study achieved average serum testosterone concentration within the normal range of 300-1050 ng/dL. Additionally, after 120 days of treatment, 75 percent of responding patients finished the study on the recommended starting dose of 60 mg.(2)
The most common adverse reactions (incidence>4%) in this Phase III study were skin application site reactions, increased red blood cell count, headache, diarrhea, vomiting and an increase in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer).(2)
About Axiron (testosterone) topical solution
Axiron is approved for replacement therapy in men for certain conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Safety and efficacy of Axiron in males younger than 18 years of age have not been established. Axiron contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroid Control Act of 2004 and can be a target for people who abuse prescription medicines. Patients should keep Axiron in a safe place to protect it. Never give it to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.