by Kristen Monaco, Staff Writer, MedPage Today March 29, 2022

The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced.

This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism.

"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 CEO of Antares Pharma.

The approval was based on a phase III trial in which about 80% of participants achieved 24-hour average serum testosterone concentrations within the normal range between 300 to 1,080 ng/dL with Tlando, meeting the primary efficacy endpoint.

Prior to treatment initiation, diagnosis of hypogonadism must be confirmed via morning measurements of serum testosterone concentrations on at least two separate days to see if levels are below the normal range.

The recommended dosage is 225 mg orally twice daily with food. It does not require dose titration.

"We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple.

The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone.

Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo.

The FDA had previously granted tentative approval to Tlando, but full approval was held off until March 27 when the exclusivity period that was granted to Clarus for Jatenzo under the Hatch-Waxman Act expired.

Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns.

Because of these concerns, the label for Tlando includes a boxed warning regarding possible blood pressure increases, stating that these "can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death."

The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment.

"Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes.

Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event.

Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S.

Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

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