LPCN 1021 filed with FDA for hypogonadism- Lipocine

Lipocine Inc has submitted a New Drug Application to the FDA for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

The NDA filing is supported by results from Lipocine's Study of Oral Androgen Replacement (SOAR) pivotal Phase III clinical study (Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (SOAR)) evaluating efficacy and safety of LPCN 1021 in hypogonadal men with low testosterone. The study met its primary efficacy endpoint by successfully restoring testosterone levels to the normal range in 88% of the subjects. In addition, 85% of the subjects reached their final dose with no more than one dose titration. LPCN 1021 treatment was well tolerated with no hepatic, cardiac, gastrointestinal or drug-related serious adverse events.