Pharmaceutical companies are working vigorously to test testosterone formulations to become the first oral testosterone treatment on the market already well populated with testosterone patches, creams, gels, implants and injections. But in order to win Food and Drug Administration (FDA) approval, they will have to prove they are safe and effective, and will be used only for the condition for which they are intended to treat.
This month, Clarus Therapeutics, Inc., announced that its proprietary oral testosterone replacement product Jatenzo, formerly named Rextoro, was currently being tested in patients under a newly launched Phase 3 clinical trial. The announcement comes two years after the FDA rejected a new drug application for Rextoro over safety concerns.
At the time, the FDA had raised concerns over inappropriate uses of testosterone replacement therapy and cardiovascular risks. Testosterone treatments are indicated for men with hypogonadism, a condition in which the body does not produce enough of the hormone due to disease, injury or defect.
Clarus says it launched the latest clinical trial “after productive dialogue with the FDA regarding the complete response letter issued for our Jatenzo (new drug application). We believe this additional trial will provide the supplemental data requested by the FDA and lead to the approval of (Jatenzo).”
The FDA is also currently reviewing an oral testosterone replacement treatment manufactured by Lipocine Inc. currently called LPCN 1021. A response is expected by June 28, 2016.
Recent studies have linked testosterone replacement therapy to serious cardiovascular risks including heart attacks, strokes and death. In March 2015, the FDA ordered tighter prescribing language on the safety labels of testosterone treatments to help curb excessive inappropriate use of the products. The agency also added new warnings regarding cardiovascular risks.