FDA Approves Oral Testosterone Replacement Tlando

The FDA has granted final approval for Tlando (testosterone undecanoate), a treatment for testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Developed by Antares Pharma, Tlando is an oral therapy that does not require dose titration. It had been granted tentative approval as a twice-daily therapy.

“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 that will continue to deliver solutions for improved patient care,” Joe Renda, senior vice president, commercial of Antares Pharma, said in a press release.

Most marketed testosterone replacement therapy products often require multiple dose adjustment clinic visits to achieve the desired testosterone levels. Investigators in a phase 3 trial said a therapy without dose titration has the potential to improve patient compliance. This study, published in the January 2022 issue of Andrology, compared a dosing regimen without titration with with the efficacy and safety obtained from the previous one-year phase 3 study of Tlando with titration.

The previous study with titration reported that 86% of subjects achieved testosterone levels within the normal range before titration and 87% were with levels within the normal range after two titrations. This study showed that a 225 mg twice a day oral dose of Tlando restored serum T levels to the normal range without the need for dose adjustment.

Antares had resubmitted the application for Tlando in February. The company had entered into a license agreement with Lipocine for the oral testosterone therapy. Antares also has an option to license and develop LPCN 1111, an investigational product containing testosterone tridecanoate.