Antares Receives FDA Approval of Testosterone Replacement Therapy

Antares Pharma announced the approval of Xyosted (testosterone enanthate) injection by the FDA. Xyosted is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. Xyosted has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).

“Today’s FDA approval of Xyosted is a significant milestone for Antares. Xyosted expands our branded portfolio of combination drug/device products and continues to highlight our passion and commitment to providing high quality therapies that improve patient care,” said Robert F. Apple, President and CEO of the Company. “Xyosted, the first subcutaneous auto injector product designed for testosterone replacement therapy will soon be available for adult males diagnosed with a deficiency or absence of endogenous testosterone. 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.” He concluded, “We believe Xyosted significantly enhances a testosterone deficient patient’s option for treatment […] We will now begin the process of onboarding sales representatives and expect to make Xyosted available to patients before the end of this year.”

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, “A once-weekly, at-home, subcutaneously administered testosterone product represents an exciting new treatment option for men suffering from hypogonadism.” He continued, “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 has been clinically shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio.”

Xyosted enters the testosterone replacement therapy market where approximately 6.5 million retail prescriptions were filled in 2017, according to data from Symphony Health Solutions. The majority of the prescriptions written were for injectable (66 percent) and topical (32 percent) testosterone products.

(Source: Globe Newswire)