First oral testosterone treatment on track to seek FDA approval

Low T1 First oral testosterone treatment on track to seek FDA approvalPharmaceutical company Lipocine Inc. is poised to gain Food and Drug Administration (FDA) approval for LPCI 1021, the first swallowable oral testosterone treatment that investors say could make the company’s shares rise more than 80 percent of all goes smoothly.

Testosterone treatments generally come in topical gels or patches that deliver testosterone through the skin, or injections that are administered with a shot. The gels are the most popular version though they carry a black box warning because they can be unintentionally transferred to women, children and pets. Thus, an oral version of testosterone would be more convenient than other testosterone therapies.

Oral versions have failed in the past because testosterone has inherently low bioavailability and a first-pass metabolism that can cause liver injuries. Lipocine’s oral testosterone treatment has shown to be effective and have less impact on the liver in early testing.

Testosterone is FDA-approved to treat hypogonadism, a condition in which the body does not produce enough testosterone due to injury or disease. Marketing campaigns waged by testosterone manufacturers have coined the phrase “Low T” to encourage men to seek treatment for symptoms of low testosterone including low libido, weight gain, muscle loss and fatigue. This has resulted in skyrocketing sales of testosterone treatments, and has left many to question whether men are actually being tested for hypogonadism before being prescribed the hormone.

The reason why overprescribing of testosterone is a concern is because testosterone replacement therapy has been linked to an increased risk of heart attacks, strokes, blood clots and death.

An FDA panel review into safety risks with testosterone therapies has resulted in rewording on the labeling of testosterone drugs to limit the prescribing of the medication for men who test positive for hypogonadism. The agency also ordered labels to include reports of cardiovascular events in men who have used the products.

Source: 247 Wall Street