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Self-Administered Testosterone Therapy Gets FDA Nod on Second Try

XYOSTED's approval comes nearly a year following Antares first received a Complete Response Letter from the FDA for its application.

The US Food and Drug Administration (FDA) has approved a first-of-its-kind self-administration subcutaneous testosterone enanthate.

The testosterone replacement therapy (XYOSTED) from Antares Pharma has been approved for adult males with a deficiency or absence of endogenous testosterone (hypogonadism). As administered as a once-weekly, single dose auto injector therapy, the device will provide the patients to take the treatment without the aid or supervision of a care provider at home. It is approved in dosage strengths of 50 mg, 75 mg, and 100 mg.

The approval comes nearly a year following Antares first received a Complete Response Letter (CRL) from the FDA for its application as a therapy for hypogonadism in adult males. The CRL identified 2 deficiencies related to the clinical data backing XYOSTED’s application, namely indications that the therapy could meaningfully increase the risks of blood pressure or depression and suicidality.

According to Symphony Health Solutions, the testosterone replacement therapy market drew approximately 6.5 million retail prescriptions in 2017—the majority (66%) being written for injectable testosterone products.

Principal XYOSTED pivotal studies investigator and New York University School of Medicine clinical assistant professor of urology Jed C. Kaminetsky, MD, said a product of its capability “represents an exciting new treatment option” in the field of hypogonadism.

“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,” Kaminetsky said. “XYOSTED has been clinically shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio.”

In a statement announcing the approval, Robert F. Apple, president and chief executive officer of Antares, said the company will now begin processes to ensure the therapy is available to patients before the end of 2018.

“Published data from the XYOSTED phase three studies have shown our product to be easy to use and virtually pain free while providing steady testosterone levels,” Apple noted. “We believe XYOSTED significantly enhances a testosterone deficient patient’s option for treatment, and I am proud of our team’s success in developing and bringing to market this novel product.”