Clinical Corner: Results with Two New Testosterone Medications
If there is one thing that underlines the growing expansion of the male HRT market in the Unites States, it is the rapid emergence of new testosterone medications. The past couple of years have seen a great deal of new drug development. We’ve had several new transdermal products approved by the FDA, including Axiron, Fortesta, and Bio-T Gel, even the higher dosed AndroGel 1.62%. Plus, we’ve heard of new generics getting ready for release. There is no shortage of interest on the part of the pharmaceutical manufacturers, suggesting that some might be predicting a gold rush in the male HRT market. One that note, reports came out this past week about two more testosterone medications that may be nearing FDA approval.
The first is a product called Compleo TRT. It is being funded by a company called Trimel Pharmaceuticals, based in Canada. The product is designed as an intranasal testosterone gel. It is not inhaled, but instead is applied to the interior lining of the nostrils with an applicator. The concentrated testosterone gel is then absorbed through the nasal mucosa, which takes about 10-15 minutes. The principle advantage to this design is that it avoids exposure of the drug to other people. This was the subject of an FDA black box warning in 2009 with transdermal products like AndroGel. The FDA had been receiving reports of women and children being affected by contact with men using the product. Compleo TRT, which should alleviate such risk, is now entering Phase III clinical trials (1).
The second drug of interest is an oral testosterone product being investigated by the pharmaceuticals giant GlaxoSmithKline. The product is called Oral T-8, and the company describes it as a “novel modified slow-release oral formulation of testosterone”. The tablet is designed to break down slowly in the digestive tract, and release testosterone into the blood stream over a period of 8 hours. The low oral bioavailability of testosterone is presumably countered by a high dose and steady delivery. Recent Phase I clinical trials found that a dosing regimen of 300 mg given three times daily was able to stabilize serum testosterone levels within the normal range for adult men within 9 days (2). The drug was initially developed as a male contraceptive, though is now being investigated for treating testosterone deficiency.