 Axiron has been approved by the U.S. Food and Drug Administration as the first topical testosterone solution to be applied to the underarm, makers Eli Lilly and Acrux said in a news release.
Previously approved forms of testosterone replacement therapy have included tablets, skin patches, injections and topical gels. As many as 13 million men aged 45 or older in the United States have symptoms of low testosterone, including decreased sexual desire, fatigue, depressed mood and osteoporosis, the companies said.
Adverse reactions reported during clinical testing of Axiron included skin reactions, increased red blood cell count, headache, diarrhea, vomiting and an increase in blood levels of Prostate Specific Antigen, a screening marker for prostate cancer.
Axiron hasn't been studied in males younger than 18, the drug makers said.
The hormone can be transferred to others via close contact. Unexpected signs of puberty have been reported among young children accidentally exposed to testosterone. Axiom users should immediately cover the applied area and wash their hands to help avoid this possibility, the companies said.
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