FDA Approves Oral Treatment For Testosterone Replacement Therapy

US Food and Drug Administration

The US Food and Drug Administration has granted approval to testosterone undecanoate (TLANDO), an oral treatment for testosterone replacement therapy.

The therapy is indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Its approval was granted to Antares Pharma, Inc.

“The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma in an accompanying statement. “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.”

Male hypogonadism is an endocrine disorder wherein the body fails to produce enough testerorine. It is estimated to affect approximately 35% of men older than 45 years of age and 30 - 50% of men with obesity or type 2 diabetes.

It is indicated for testorone replacement therapy for adult males with conditions including primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The safety and efficacy of the oral treatment has not been established in males less than 18 years old.

The company is looking to launch the oral treatment to provide a complementary treatment option to patients and clinicians in the second quarter of 2022.

“We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market,” commented Joe Renda, Senior Vice President, Commercial of Antares Pharma. “Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO."

Renda additionally noted the uniqueness of the product will benefit patient-centric care and separate it from other treatment options.

“With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options,” he added. “We believe TLANDO’s oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options.”