Clarus Therapeutics, an emerging men’s health specialty pharmaceutical company, filed with the Securities and Exchange Commission (SEC) this week to raise up to $86 million in an initial public offering. The biotech company is preparing for the commercial launch of REXTORO, an oral testosterone replacement therapy for which the company has submitted a New Drug Application with the Food and Drug Administration (FDA).
If approved, REXTORO will be the first oral testosterone treatment available in the United States. The drug is intended to boost testosterone levels in men with low testosterone levels, also known as hypogonadism.
The term “Low T” has also been coined by testosterone supplement manufacturers to describe the condition. Men with low testosterone levels often experience symptoms such as diminished sex drive, fatigue, weight gain, and loss of muscle mass.
Currently marketed testosterone treatments include AndroGel, Axiron and Testim, which are gels that are applied to the skin. Men who use the gels are instructed to thoroughly wash their hands after applying the gel and to cover treated skin with clothing to avoid accidentally exposing women and children to the gel. As an oral treatment, REXTORO will not have the risk of testosterone transference to others.
Clarus says it expects its testosterone treatment to be reviewed by FDA advisors in November. One issue drug regulators will be weighing is side effects of testosterone therapy, some of which could be deadly. Recent studies have linked testosterone treatment to an increased risk of heart attacks, strokes and death, especially in older men and men with heart disease.