Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
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Antares Pharma announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT). The treatment is specifically indicated for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males.
The approval comes after a long regulatory journey for the therapeutic. In June 2016, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) submitted by Antares and its partner Lipocine. The CRL identified the generalizability of the titration scheme as the deficiency and recommended that Lipocine validate the proposed dosing regimen. The NDA was resubmitted in Aug. 2017 after obtaining results investigating dosing validation and flexibility. The FDA issued another CRL identifying four more deficiencies that the companies would need to address. This includes evaluating changes in blood pressure in those treated with Tlando. A meeting in 2018 took place with the FDA to identify a path forward for NDA resubmission.
Now, Aretas and Lipocine rejoice as the FDA has fully approved the therapeutic. In Phase III clinical trials of Tlando evaluating 315 subjects, 87% of participants dosed achieved concentration testosterone levels within the normal range. The drug was also well tolerated with only mild to moderate drug-related adverse events being reported.
“We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market,” Antares SVP of Commercial Joe Renda said. “We believe TLANDO’s oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options.”
Tlando offers patients unique benefits. As an oral testosterone treatment, it has several advantages over topical and injectable TRTs that both contain Black Box Warnings, the FDA’s most stringent warning indicating the drug has serious side effects that could include death. Additionally, topical TRTs are messy to apply and cannot be used around pregnant women, and injectable TRTs offer disadvantages like chances for anaphylaxis shock and risk of infection.
Although other oral testosterones are on the market, they can require frequent dosing due to short half-lives and certain types of oral TRTs can produce liver issues in patients. Other key advantages listed by Lipocine for Tlando include no risk of accidental testosterone transference, ease of use and potential for higher adherence by patients. It also offers a fixed dosing regimen, which means fewer doctor visits for patients as there is no need for dose adjustment visits.
Adherence to TRT is an essential issue for those suffering from hypogonadism. Hypogonadism occurs when the body doesn’t produce enough testosterone and can be present from birth or develop later in life, sometimes from injury or infection. An estimated four to five million men in the United States are affected by hypogonadism and those with Type II Diabetes are at a higher risk of developing the condition.
In adult males who develop hypogonadism, symptoms can include decreased sex drive, decreased energy and depression. Over time, without treatment, the condition can cause infertility, decrease in muscle mass and loss of bone mass. Engaging in TRT can help combat these symptoms in those with the condition improving overall health and quality of life.
