Lipocine: LPCN 1021 Meets FDA Primary Efficacy Guideline - Quick Facts

(RTTNews) - Lipocine Inc. (LPCN) announced positive top-line efficacy results from its ongoing Study of Oral Androgen Replacement pivotal Phase 3 clinical study, evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone. The company said, overall, the study demonstrated positive results with respect to the trial's primary efficacy endpoint with no serious adverse events.

The primary efficacy end point of the study was the percentage of subjects with an average 24 hour serum testosterone concentration (Cavg) within the normal range, which is defined as 300-1140 ng/dL, after 13 weeks of treatment. LPCN 1021 successfully met the FDA primary efficacy guideline.

Lipocine continues to expect to file a NDA with the FDA in the second half of 2015. Mahesh Patel, CEO of Lipocine, stated, "We look forward to reporting additional safety results from this ongoing study."