FDA Approves First Underarm-Applied Testosterone Replacement Therapy
2010-12-03
INDIANAPOLIS, Indiana and MELBOURNE, Australia -- November 29, 2010 -- The US Food and Drug Administration (FDA) has approved testosterone (Axiron) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone. This is the first FDA-approved testosterone replacement therapy (TRT) that is applied to the underarm, like deodorant.
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, US estimates suggest that up to 13 million men over 45 years of age may have symptoms associated with low testosterone. Clinical trial data indicated that the underarm-applied TRT, sold as Axiron, can restore blood concentration of testosterone within the normal range in most men.
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. 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.
Findings from a phase 3, multicentre, open label, 120-day clinical study demonstrated that 84% 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% of responding patients finished the study on the recommended starting dose of 60 mg.
The most common adverse reactions (incidence >4%) in this phase 3 study were skin application site reactions, increased red blood cell count, headache, diarrhoea, vomiting and an increase in prostate specific antigen levels.
This topical, alcohol-based testosterone solution is applied to the underarm once daily using a metered dose applicator. Patients who use antiperspirant or deodorant should apply it first, before applying the TRT, to avoid contamination of the deodorant.
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, US estimates suggest that up to 13 million men over 45 years of age may have symptoms associated with low testosterone. Clinical trial data indicated that the underarm-applied TRT, sold as Axiron, can restore blood concentration of testosterone within the normal range in most men.
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. 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.
Findings from a phase 3, multicentre, open label, 120-day clinical study demonstrated that 84% 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% of responding patients finished the study on the recommended starting dose of 60 mg.
The most common adverse reactions (incidence >4%) in this phase 3 study were skin application site reactions, increased red blood cell count, headache, diarrhoea, vomiting and an increase in prostate specific antigen levels.
This topical, alcohol-based testosterone solution is applied to the underarm once daily using a metered dose applicator. Patients who use antiperspirant or deodorant should apply it first, before applying the TRT, to avoid contamination of the deodorant.
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