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oral testosterone replacement therapy 2 articles

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

FDA to consider approval of first oral testosterone treatment

Lipocine Inc., a specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in hopes of gaining approval of the first oral testosterone replacement therapy for adult males with hypogonadism, a condition in which men do not produce enough testosterone due to disease or defect. The FDA says it expects to have its review of the drug, known as LPCN 1021, completed by June 28, 2016. Testosterone treatments are currently available by prescription in topical gels, patches, nasal sprays, and injections. Oral versions of the hormone have been difficult to formulate because the ... Read More