FDA approves injectable agent for hypogonadism

The FDA has approved testosterone undecanoate (AVEED) injection for treatment of men with hypogonadism.

Testosterone undecanoate is indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750-mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

The drug’s approval is based on data from an 84-week phase III trial of hypogonadal U.S. men. Patients enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. In the study, testosterone undecanoate increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14 and 24). Testosterone undecanoate is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.

"Physicians have prescribed FDA-approved testosterone replacement therapies for many years to help treat men diagnosed with testosterone deficiency, or hypogonadism. AVEED is an important new option that may be suitable for some men given its dosing schedule and administration," said Martin Miner, MD, of the Men's Health Center at Miriam Hospital and Brown University's Warren Alpert School of Medicine, Providence, RI. "As with any prescription therapy, hypogonadal men should talk to their doctor about the potential risks and benefits of testosterone replacement therapy so they can make an informed treatment decision."

The approval of testosterone undecanoate “occurs right in the middle of new concerns regarding cardiovascular risks for testosterone therapy,” said Abraham Morgentaler, MD, of Men's Health Boston and Harvard Medical School.

“On a scientific level, the two recent studies suggesting increased risks provide no credible evidence that testosterone therapy is risky,” he said. “However, perception is often more important than reality. The decision by the FDA to approve AVEED at this time likely means the agency is likewise unimpressed by breathless concerns regarding risks.”

The FDA has indicated that it intends to review the cardiovascular risk associated with testosterone replacement therapy in men with hypogonadism, and both the American Urological Association and Endocrine Society recently released separate statements on the treatment, each with varying degrees of caution.

In a statement from Endo, the non-profit educational organization Men’s Health Network applauded testosterone undecanoate's approval.

"Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, Men's Health Network. "Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."

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