U.S. drug regulators gave Irish drugmaker Endo Pharmaceuticals the green light to manufacture and market its long-lasting testosterone injection Aveed in the United States, making it the latest addition to a growing list of testosterone-replacement therapies drug companies are aggressively marketing to men in the U.S. and other countries.
Endo Pharmaceuticals said the U.S. Food and Drug Administration (FDA) approved Aveed to treat men with hypogonadism, commonly referred to as “low testosterone” or “low T,” a condition in which the body produces lower than normal levels of the hormone. Men with abnormally low testosterone levels often experience declines in muscle, energy, and libido. Weight gain and depression are also associated with low testosterone in some cases.
Endo’s injectable testosterone drug is to be administered once every 10 weeks, making it more convenient than similar drugs that must be injected weekly or biweekly. The FDA rejected the drug in 2008 and again last May over concerns about the castor oil in the drug and the potential risk of that ingredient to cause vascular blockages in the lungs and other post-injection reactions and complications.
The FDA finally granted Aveed approval after accepting a risk evaluation and mitigation strategy (REM) proposed by Endo that requires patients to remain in the administering physician’s office or clinic for at least 30 minutes after the injection so that short-term reactions could be observed and treated.
The FDA also overrode the objections of consumer safety advocates who urged the agency to delay its approval of Aveed, arguing that stronger warnings are needed for testosterone-replacement drugs because of adverse effects the drug can have on the heart.
Testosterone drugs are generating billions of dollars in annual revenue for drug companies, with easy-to-use topical gels such as AbbVie’s AndroGel taking the lion’s share. Last year, U.S. sales of that drug generated more than $2 billion, and that number is expected to more than double within the next three years.
Many analysts predict that testosterone drug sales overall will triple within the next five years, thanks mainly to extremely effective direct-to-consumer advertising.
Endo’s Aveed expects to begin selling Aveed in the U.S. this month.