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Lipocine 5 articles

FDA panel shoots down oral testosterone therapy

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 ... Read More

FDA considers first oral testosterone treatment

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 ... Read More

Lipocine conducts dosing study on testosterone pill despite new warnings

Specialty drug maker Lipocine Inc., has launched a dosing validation study based on feedback from the Food and Drug Administration (FDA) regarding the protocol for LPCN 1021, the company’s oral testosterone replacement candidate for men with hypogonadism, a hormone deficiency condition in adult men. Lipocine had sought FDA approval earlier in 2016 but was shot down by regulators who questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. The special protocol assessment and validation study are needed in order to secure FDA approval. Lipocine plans to enroll 100 hypogonadal ... Read More

Testosterone companies fight over patent infringement

A patent infringement lawsuit filed against drug maker Lipocine Inc. by Clarus Therapeutics was dismissed by the U.S. District Court in Delaware. Clarus was suing Lipocine over claims that Lipocine’s key drug candidate, LPCN 1021, infringed Clarus’ patent of Clarus’ similar drug JATENZO. LPCN 1021 and JATENZO are experimental oral testosterone replacement therapy currently in Phase III clinical trials. They are designed for boost levels of the male hormone in men with hypogonadism, a deficiency of testosterone due to disease or defect. Testosterone treatments are generally administered by injection, topical gel, or nasal spray. Both LPCN 1021 and JATENZO aim ... Read More

Experimental testosterone pill raises long-term safety concerns

Drug maker Lipocine Inc., is poised to gain Food and Drug Administration (FDA) approval for the first oral testosterone replacement therapy, LPCN 1021. Other testosterone products on the market come in topical gels, patches nasal sprays, or injections. LPCN 1021, Lipocine claims, would offer another option for men who suffer from low testosterone. Oral versions of testosterone have been difficult to formulate because the liver readily deactivates the oral testosterone. This can damage the liver as well as lower HDL cholesterol, considered the “good” cholesterol. Lipicine’s press release touts studies that said LPCN 1021 was “shown to be safe and efficacious.” ... Read More