Two drug companies – both plagued by fits and starts– are racing to see which will be the first to gain Food and Drug Administration (FDA) approval for the first testosterone pill that can be taken by mouth.
This week Lipocine announced it had resubmitted a New Drug Application (NDA) to the FDA for LPCN 1021, it’s oral testosterone replacement therapy designed to boost testosterone in men with low levels of the male hormone, a condition called hypogonadism.
Lipocine had previously submitted an NDA to the FDA in June 2016 but was rejected. The agency cited problems with the dosing algorithm for the proposed label. Lipocine says it has completed a dosing validation study that confirms the validity of a fixed dose approach without need for dose titration. The company is also submitting efficacy results of the dosing validation study and an integrated safety set from all previously conducted clinical trials in hopes of obtaining FDA clearance.
Liposine’s NDA comes a month after Clarus Therapeutics resubmitted its NDA for Jatenzo, another oral testosterone product. Jatenzo was initially submitted in early 2014 under the name Rextoro, but was rejected by the FDA over safety and efficacy concerns.
Testosterone replacement treatments come in a variety of forms including injections, gels, nasal sprays and transdermal patches. An oral version would offer more convenience to patients, the drug companies argue.
If approved, the oral testosterone treatments would hit the market as sales of hormone replacement therapy are beginning to decline. Testosterone manufacturers have come under fire for heavily marketing their products directly to consumers – often for unapproved uses – which caused a spike in prescriptions leading the FDA to require the drug companies to clarify that testosterone treatments are only for men with hypogonadism due to injury or disease. Testosterone therapy has also been linked to cardiovascular risks including heart attacks, strokes and blood clots, some of which have been fatal.
Makers of testosterone treatments face thousands of lawsuits alleging they did not adequately warn men that the drugs could cause serious cardiovascular risks and for pushing the product for off-label uses. Last month, an Illinois federal jury ordered AbbVie, maker of AndroGel, to pay $150 million to an Oregon man who suffered a heart attack while using AndroGel, for misrepresenting the risk of low testosterone treatment.