FDA to consider review of first oral testosterone product

Low T1 FDA to consider review of first oral testosterone productJust weeks after the Food and Drug Administration (FDA) ordered manufacturers of testosterone replacement therapies to collect data involving cardiovascular risks in patients who used their products, another drug company announced it was seeking FDA approval on a new oral testosterone supplement.

Drug maker Lipocine announced it had submitted a new drug application (NDA) to the FDA for LPCN 1021, its experimental twice-daily, oral testosterone treatment. The drug is intended for men with conditions related to a deficiency or absence of endogeneros testosterone, a condition known as hypogonadism.

The application for LPCN 1021 includes data from a pivotal Phase 3 clinical study testing the hormone’s safety and efficacy on hypogonadal men. The company says its treatment restored testosterone to the normal range in 88 percent of participants, and 85 percent of them reached their final dose with a single dose titration.

Testosterone replacement products are available in gels, patches, and injections. Oral versions of testosterone 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 product has been shown in studies to have less impact on the liver.

Aggressive marketing of testosterone products has resulted in skyrocketing sales of the hormones, and has raised red flags involving the overprescribing of testosterone especially to men who do not have hypogonadism. Studies have linked testosterone therapy to an increased risk of heart attacks, strokes and death.

An FDA review has resulted in tighter prescribing of testosterone products and added warnings for blood clots and cardiovascular risks. To better understand these risks, the FDA recently required testosterone manufacturers to collect data on cardiovascular adverse events in patients treated with their drugs.

Source: Pharmaceutical Business Review