TLANDO, an Oral Option for TRT for Men, Approved by US FDA

Patients in the US will soon have an oral treatment option for testosterone therapy thanks to the US Food and Drug Administration (FDA) approval of testosterone udecanoate (TLANDO) for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males.

With approval granted to Antares Pharma, which also owns the rights to testosterone enanthate (XYOSTED), testosterone udecanoate is expected to be available within the US in Q2 2022, according to a statement from Antares Pharma.

“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.

“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,” Apple continued later in the statement.

According to the statement from Antares Pharma, testosterone udecanoate is contraindicated in patients with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, those with a known hypersensitivity to testosterone udecanoate or any of its ingredients, and in men with hypogonadal conditions not associated with structural or genetic etiologies. In their statement, Antares Pharma also noted testosterone udecanoate is known to cause blood pressure increases and clinicians should consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled before initiating testosterone udecanoate.

“We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO," said Joe Renda, Senior Vice President, Commercial of Antares Pharma. "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. We believe TLANDO’s oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options”