Lipocine Inc., a specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in hopes of gaining approval of the first oral testosterone replacement therapy for adult males with hypogonadism, a condition in which men do not produce enough testosterone due to disease or defect. The FDA says it expects to have its review of the drug, known as LPCN 1021, completed by June 28, 2016.
Testosterone treatments are currently available by prescription in topical gels, patches, nasal sprays, and injections. Oral versions of the hormone have been difficult to formulate because the liver readily deactivates the oral testosterone. This can damage the liver and also can lower levels of HDL cholesterol, considered the “good cholesterol.”
In January 2014, Clarus Therapeutics submitted an NDA to the FDA for an oral testosterone formulation known as Rextoro. But in September of that year, an FDA advisory panel voted against approving the drug due to safety concerns.
At the time, the FDA was raising concerns of overuse and inappropriate use of testosterone replacement therapy, as well as safety concerns. Studies showed that many men who were prescribed testosterone treatments were never tested to see if they suffered from low testosterone. Furthermore, makers of testosterone treatments were pushing sales through direct-to-consumer marketing campaigns that coined the phrase “Low-T” and encouraged use for low libido, muscle loss and weight gain.
The FDA ultimately tightened the indication for testosterone replacement therapies, saying that the drugs were not suitable for men with naturally occurring age-related hypogonadism.
The agency also expressed safety concerns with testosterone treatments in general. Studies have shown that men who use testosterone treatments are at an increased risk of heart attacks, strokes, blood clots and death.