Health Canada Approves New Testosterone Topical Solution for Men

Axironis the only approved testosterone replacement therapy with innovative application device

TORONTO, May 14, 2012 /CNW/ - Axiron (testosterone topical solution, 2%) has been approved by Health Canada for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

Axiron is a first-of-its-kind. It is a topical, alcohol-based testosterone solution applied to the underarm once daily using a metered dose applicator that avoids contact with the hands. The recommended starting dose is 60 mg once daily, preferably applied at the same time each morning.1

"The approval of Axiron signals valuable innovation in the treatment of male testosterone deficiency," says Dr. Serge Carrier, Urologist, McGill University. "With its novel applicator and odorless solution that dries in around two minutes, Axiron offers a treatment regimen that fits more naturally with a man's daily routine."

Clinical trial data indicated that Axiron can restore blood concentration of testosterone within the normal range in most men.2

Axiron is expected to be available in Canada in the first quarter of 2013 and will provide a new option for healthcare professionals helping to treat the signs and symptoms of testosterone deficiency.

The product expands Eli Lilly Canada's focus in men's health and is a strong strategic fit within Lilly Bio-Medicines, alongside Cialis.

About Testosterone Deficiency Testosterone deficiency, also known as hypogonadism or low testosterone, is a clinical condition in which the body does not produce enough of the hormone testosterone.3 Approximately 25 per cent of Canadian men between the ages of 40 and 62 years are biochemically testosterone deficient. Testosterone deficiency syndrome is an under-recognized condition and less than 10 per cent of those affected receive the proper treatment.4

Signs/symptoms associated with testosterone deficiency can include decreased sexual desire with or without erectile dysfunction, fatigue and loss of energy, mood depression/ disorder and depressive symptoms, regression of some secondary sexual characteristics and osteoporosis, weakness, irritability and decreased motivation.1

About the Axiron Phase III Study The data submission package for Axiron included findings from a Phase III multi-centre, open label, 120-day clinical study, which demonstrated that 84 per cent of men who completed the study achieved average serum testosterone concentration within the normal range of 10.4 - 36.4nmol/L (300 - 1050 ng/dL). Additionally, after 120 days of treatment, 75 per cent of responding patients finished the study on the recommended starting dose of 60 mg.1

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Health Canada Approves New Testosterone Topical Solution for Men

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