Lipocine Inc.’s journey to Food and Drug Administration (FDA) approval for the first testosterone pill known as LPCN-1021 has been rife with obstacles.
In June, regulators rejected the company’s bid for marketing approval for the synthetic hormone pill, saying there were deficiencies related to the dosing algorithm that would first need to be ironed out. The company responded by submitting a new dosing validation study protocol, which the FDA agreed to review under a special protocol assessment (SPA). If the SPA is approved, Lipocine would need to carry out the validation study in order to secure another review.
Just as Lipocine edges toward FDA approval, more warnings have surfaced about the use of testosterone replacement therapies. Last month, the FDA warned that prescription testosterone therapies and other anabolic androgenic steroids (AAS) were associated with abuse risks as well as numerous health risks including cardiovascular events, mental health effects, and severe withdrawal symptoms.
That warning came just months after the FDA warned testosterone could cause blood clots, heart attacks, strokes and death, and that the products were being overprescribed, often to men who did not quality for treatment under the indicated guidelines of hypogonadism.
Testosterone replacement therapy, however, has become a booming business raking in a half million prescriptions each month of 2016. Drug Watch has predicted sales of testosterone products could reach $5 billion by 2017, an overwhelming jump from $2 billion in 2012.
Testosterone supplements are sold in gels, topical creams, nasal sprays, patches and injections. Oral formulations have been difficult to make. LPCN 1021, a pill version of testosterone, would offer a more convenient alternative.
While it is poised to be the first oral testosterone product to gain FDA approval, it is not without competition. Clarus Therapeutics is currently running clinical trials on its proprietary oral testosterone replacement product Jatenzo, formerly named Rextoro, and is expected to be reviewed by an FDA advisory panel in December 2016.