The Food and Drug Administration (FDA) has rejected the new drug application for Lipocine, Inc.’s LPCN 1021, poised to be the first testosterone pill on the market, due to dosing discrepancies.
The FDA issued a complete response letter (CRL) to Lipocine informing the company that its application could not be approved in its present form. The issues involve deficiencies related to the dosing algorithm for the LPCN 1021 label. Lipocine said it plans to request a meeting with the FDA to determine next steps for approving the oral testosterone therapy.
LPCN 2012 is a twice daily oral testosterone replacement therapy for men with hypogonadism, a condition in which the body produces low levels of the hormone testosterone due to disease, injury or defect. There is currently no oral testosterone treatment product on the market. FDA-approved therapies include injections or topical gels and creams.
Testosterone pills have been difficult to formulate because the liver readily deactivates the oral testosterone, which can damage the liver as well as lower levels of HDL cholesterol, considered the “good” cholesterol.
Testosterone treatments in general have skyrocketed in recent years, leading the FDA to urge health care professionals to only prescribe the medication for men with documented hypogonadism and not age-related decreases in testosterone. The agency also added new warnings for blood clots, heart attacks, strokes and death risks after studies suggested testosterone treatments could increase cardiovascular risks.
Despite these health concerns and Lipocine’s rejection, Clarus Therapeutics, Inc. is currently running clinical trials on its proprietary oral testosterone replacement product Jatenzo, formerly named Rextoro.