A Food and Drug Administration (FDA) advisory panel voted not to approve Lipocine Inc.’s oral testosterone replacement treatment called Tlando, citing safety concerns involving blood pressure and heart rate, hematocrit, and serum lipids.
Tlando, previously known in studies as LPCN 1021, are capsules that contain 112.5 mg testosterone undecanoate, an esterified testosterone derivative, combined with a propriety lipid formulation. Once taken orally, the testosterone is systematically absorbed primarily through the lymphatic system.
The FDA’s Bone, Reproductive, and Urological Drugs Advisory Committee (BRUDAC) voted six in favor and 13 against approval of the drug based on its benefit/risk profile. The FDA is not required to follow the recommendations of its advisory panel, but it usually does. If approved, Tlando will be the first oral testosterone treatment.
Tlando has had a difficult time gaining approval from the FDA panel. The specialty drug maker sought approval earlier in 2016 but was shot down by regulators who questioned the dosing algorithm.
Clarus Therapeutics is also vying for approval of an oral testosterone therapy, Jatenzo, formerly named Rextoro. Currently, marketed testosterone treatments come in injections, gels, nasal sprays and patches.
The drug companies are seeking FDA approval on testosterone therapies while the drugs are under much scrutiny. Testosterone manufacturers are facing thousands of lawsuits in a multidistrict litigation that claim they aggressively marketed the hormones for off-label use and did not warn that using testosterone supplements could increase the risk of cardiovascular side effects including blood clots, heart attacks, strokes and death.