Eli Lilly and Company (NYSE: LLY) announced today that Axiron® (testosterone) topical solution is available in pharmacies throughout the United States. Axiron is a prescription medicine used to treat adult males that have low or no testosterone. Safety and efficacy of Axiron in males younger than 18 years of age have not been established.
The U.S. Food and Drug Administration (FDA) approved Axiron on November 23, 2010, making it the first and only testosterone replacement therapy applied to the underarm. Other forms of testosterone replacement therapies include: buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels.
"Currently, healthcare professionals and patients have access to topical testosterone treatment options that are applied to various areas of the skin. Axiron offers a new application method for patients to apply testosterone to the underarm using an applicator," said Dr. Ronald Swerdloff, clinical trial investigator, Los Angeles Biomedical Research Institute, and professor of medicine, University of California, Los Angeles, CA. "It is important to have different options available for treating low testosterone to help a patient select an option that's best for him."
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.
Axiron has been shown to restore testosterone levels to within the normal range in most men. The most common side effects of Axiron are skin redness or irritation where Axiron is applied, 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).
"Lilly has built a strong reputation in men's health by providing innovative treatment options to patients and physicians," said David Ricks, president, Lilly USA. "The addition of Axiron to our product portfolio allows us to build on that momentum and provide an innovative solution to patients who have a testosterone deficiency."