FDA approves testosterone self-injection for hypogonadism in men

The FDA on Monday approved Antares Pharma’s testosterone enanthate injection Xyosted for testosterone replacement therapy in men with primary hypogonadism or hypogonadotropic hypogonadism, the company announced in a press release.

The androgen is to be administered weekly and will be available in 50-mg, 75-mg and 100-mg doses in a single-use, disposable QuickShot injection device for use at home, according to the release.

“A once-weekly, at-home, subcutaneously administered testosterone product represents an exciting new treatment option for men suffering from hypogonadism,” Jed C. Kaminetsky, MD, a urologist at University Urology Associates, medical director of Manhattan Medical Research, clinical assistant professor of urology at New York University School of Medicine and principal investigator in the Xyosted pivotal studies, said in the release. “The subcutaneous dosing of Xyosted also removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits.”

Xyosted will carry a boxed warning alerting patients and prescribers to possible increases in blood pressure that can lead to cardiovascular events.