Estimated in the United States, up to 13 million men over 45 years of age have symptoms associated with low testosterone. 2 Men over the age of 50, estimated to have below normal healthy testosterone, range from 10% to 39%. "However, in the majority of men this remains undiagnosed with only 5% to 10% of those with the condition receiving treatment." 6
Currently, testosterone medication available to treat hypogonadism in men includes tablets, patches, injections and topical gels applied by the hands. In November 2010, the Food and Drug Administration approved Axiron: First underarm testosterone replacement topical solution (Alcohol-based 2) application for male testosterone deficiency. 2 Axiron developed by Acrux Ltd, Australian Drug Company. Eli Lilly purchased the worldwide license agreement with Acrux to commercialize Axiron. According to the agreement: Acurx and Eli Lily upon approval of Axiron by the FDA: "In exchange for commercialization rights, Acrux receives an upfront payment of $50 million plus $3 million on the transfer of manufacturing assets, and $87 million, following the regulatory approval." Also, Acrux may collect up to $195 million in potential royalty payments on future global sales. Axiron is anticipated to be available for male testosterone therapy in 2011. The medication will contribute to the $1 billion United States market annum testosterone therapy, growing at rate of twenty percent annually. 5
Acrurx study of Axiron 155 male participants in six countries and 26 sites: "Axiron spray restored levels of testosterone to normal in 84 percent of testosterone-deficient men after four months." The armpit application of Axiron provides a fast-dying and pleasant smelling transdermal drug delivery solution once daily. Men reported experiencing twice as much sex and 80 percent more libido on average, after applying Axiron. "Men under the study also had a 35 percent increase in sexual performance and a 13 percent increase in positive mood." During the study, use of deodorant or antiperspirant did not affect the analysis study of Axiron. 6 Studied participants common adverse reaction increase red blood cell count, headache, diarrhea, vomiting and an increase in blood level of Prostate Specific Antigen ("a test used to screen prostate cancer."). Axiron should be discontinued if the medication causes swelling of the ankles, feet or body, enlarged or painful breasts, problems with breathing, consult your physician. 2 "However, the safety and efficacy of Axiron in men younger than 18 years of age have not been established, the company noted (Eli Lilly)" 5
Recommended after applying Axiron (using the applicator), wash your hands with soap & water and cover the application area with a cloth, once the solution has dried. "Keep the area covered until you have washed the application area well or have showered." Prevent the exposure of the armpit medication from contacting the skin of another person especially a child or a woman. "Do not use Axiron if you have or might have prostate cancer, have breast cancer, are pregnant or may become pregnant or are breast-feeding." The medication may not be advisable for application, when taking vitamins, herbal supplements, prescriptions and non-prescriptions, consult your health care provider or physician. 2
In 2009, Acrux confirm in a published United States market research report: Two-Thirds of patients would prefer Axiron compared to their current gel treatment (testosterone replacement) and 87% of physicians said would offer Axiron to their patients that currently use gels. 6
References:
1.) Hypoogonadism:
http://www.nlm.nih.gov/medlineplus/ency/article/001195.htm
2.) FDA Approves Axiron - http://www.drugs.com/newdrugs/lilly-acrux-receive-fda-approval-axiron-testosterone-topical-solution-ciii-2456.html
3.) Male hypogonadism - http://www.mayoclinic.com/health/male-hypogonadism/DS00300/DSECTION=symptoms
4.) Male Hypogonadism - Causes - http://www.mayoclinic.com/health/male-hypogonadism/DS00300/DSECTION=causes
5.) Eli Lilly Says FDA Approved Testosterone Replacement Therapy Axiron - http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1489002
6.) Testorone underam spray Axiron to boost sex drive in men from Acrux on way - http://www.dancewithshadows.com/pillscribe/testosterone-underarm-spray-axiron-to-boost-sex-drive-in-men-from-acrux-on-way/
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