Clinical trials for Clarus Therapeutic’s new testosterone replacement treatment Rextoro show the drug is comparable to other testosterone therapies and, if approved by the Food and Drug Administration (FDA), could provide patients with yet another treatment option to boost the amount of the male hormone in their systems.
Rextoro is a softgel capsule that contains a testosterone prodrug, testosterone undecanoate, or TU. It is formulated to foster absorption via the intestinal lymphatic pathway. After oral TU is absorbed, natural enzymes in the body cause testosterone to be released from the prodrug.
“This proprietary formulation enables us to increase the amount of TU per softgel capsule, enhance rapid solubilizatin and bioavailability of TU and reduce the impact of food effects,” Clarus Therapeutics explains on its website.
Testosterone replacement products are designed to boost testosterone levels in men with a condition known as hypogonadalism, or low T. The condition can result in symptoms such as low sex drive, fatigue, weight gain and muscle loss.
Sales of testosterone supplements have skyrocketed in recent years, leading some to speculate whether many of the men prescribed the drugs actually have low T, or they have been lured by advertising by pharmaceutical companies promising the fountain of youth.
Testosterone products come in gels, creams, injections and other formulations. Oral formulations of testosterone have been challenging to produce due to numerous physiologic and formulation challenges. Researchers with Clarus Therapeutics spent years developing the new softgel. The company has already won regulatory approval of the first testosterone gel, AndroGel.
Clarus Therapeutics says its softgel capsule is a more convenient option because the pills are easy to swallow, and there is no inadvertent testosterone exposure to women or children as with gels.
Testosterone therapy can reduce symptoms of low T, however recent studies have linked the drugs to an increased risk of heart attacks, strokes and deaths particularly in older men and men with heart problems.