FDA OKs Jatenzo Oral Testosterone Replacement for Certain Forms of Hypogonadism

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The US Food and Drug Administration (FDA) has approved oral testosterone undecanoate (Jatenzo, Clarus Therapeutics) to treat men with hypogonadism resulting from specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.

Jatenzo should not be used to treat men with age-related hypogonadism, even if such patients have symptoms that appear to be related to low testosterone. For patients with age-related hypogonadism, Jatenzo's benefits do not outweigh its risks, the FDA said in a news release announcing approval.

"Jatenzo's oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected," Hylton V. Joffe, MD, director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in the release.

"But it's important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with 'age-related hypogonadism.' The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo's effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population," said Joffe.

An FDA advisory panel previously voted against approval of oral testosterone undecanoate and a similar product (Tlando, Lipocine), citing concerns that ease of use – and the potential for cardiovascular side effects – could expose millions to unnecessary risk.

Jatenzo was assessed in a 4-month clinical trial that involved 166 men with hypogonadism. Participants were initially given Jatenzo at a dose of 237 mg twice daily. The dose was adjusted downward or upward to a maximum of 396 mg twice daily, depending on testosterone level.

Results showed that 87% of men treated with Jatenzo achieved an average testosterone level within the normal range (the primary endpoint), the FDA said.

Side effects seen in trials of Jatenzo included headache, an increase in hematocrit level, a decrease in HDL cholesterol level, high blood pressure, nausea, and an increase in prostate specific antigen (PSA) level. For patients taking Jatenzo, hematocrit, cholesterol, and PSA levels should be monitored regularly, and patients with benign prostate hyperplasia should be monitored for worsening of symptoms, the FDA said.

Jatenzo's label contains a boxed warning about blood pressure elevations. Healthcare providers should consider individual patients' risk for heart disease and ensure that blood pressure is adequately controlled before prescribing Jatenzo, the FDA said. Blood pressure should be periodically monitored during treatment.

The FDA requires that all manufacturers of testosterone products conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure.

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