FDA Approves Oral Testosterone Replacement Therapy for Hypogonadism

The FDA has approved the oral drug estosterone undecanoate (Tlando; Antares Pharma, Inc) for testosterone replacement therapy (TRT) for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult patients.

“The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of Tlando,” said Robert F. Apple, president and chief executive officer of Antares Pharma, in a press release. “This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both Tlando and Xyosted and support our future growth with an expanded commercial portfolio. We look forward to launching Tlando commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.”

Male hypogonadism is an endocrine disorder in which the body is unable to produce enough testosterone. The condition is estimated to affect approximately 35% of men 45 years of age and older, as well as 30% to 50% of men with obesity or type 2 diabetes.

Tlandois indicated for TRT in adult males with conditions such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The safety and efficacy of Tlandohas not been established in males under 18 years of age.

Antares Pharma said it will seek to launch Tlandoin the second quarter of 2022 to provide a complementary treatment option for patients and clinicians

“We believe Tlando’s oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of Xyosted, Tlando and Nocdurna that will continue to deliver solutions for improved patient care,” said Joe Renda, senior vice president, Commercial of Antares Pharma, in a press release.

Reference

Antares Pharma Announces FDA Approval Of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy Commercial launch expected in 2Q 2022. Antares Pharma. [news release]. March 29, 2022. https://www.biospace.com/article/releases/antares-pharma-announces-fda-approval-of-tlando-an-oral-treatment-for-testosterone-replacement-therapycommercial-launch-expected-in-2q-2022/