Topline safety results from Phase III trial of LPCN 1021 in hypogonadal men- Lipocine

Lipocine announced top-line 52-week safety results from its SOAR pivotal Phase III clinical study evaluating efficacy and safety of LPCN 1021, an oral testosterone product candidate, in hypogonadal men with low testosterone. Overall, LPCN 1021 was well tolerated with no hepatic, cardiac or drug-related SAE's reported. The only AE's occurring in more than 5% of subjects with either LPCN 1021 or the active control were upper respiratory tract infection (5.2% with LPCN 1021 and 5.8% with active control) and fatigue (2.4% with LPCN 1021 and 6.7% with active control).

Any SAE and cardiac AE profiles were consistent between treatment groups. Drug-related AEs, occurring in more than 2% of subjects with either LPCN 1021 or active control were headache (0.5% with LPCN 1021 and 3.9% with active control), acne (2.9% with LPCN 1021 and 2.9% with active control) and patient reported weight increase (2.4% with LPCN 1021 and 0% with active control). The company still expects to file a New Drug Application with the FDA in the second half of 2015.