Lipocine announced top-line results from its Phase 3 Study of Oral Androgen Replacement (SOAR) clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.

SOAR is a randomized, open-label, parallel-group, active-controlled clinical study of oral testosterone in hypogonadal males with low testosterone (<300ng/dL). A total of 210 males were randomized to LPCN 1021 and 105 were randomized to the active control, for 52 weeks of treatment. LPCN 1021 subjects were started at 225mg testosterone undecanoate twice daily with a standard meal and then dose titrated, if needed, up to 300mg twice daily or down to 150mg twice daily based on serum testosterone measured during weeks 3 and 7.

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The primary efficacy endpoint of the percentage of subjects with an average 24-hour serum testosterone concentration (Cavg) within the normal range, which is defined as 300–1140ng/dL, after 13 weeks of treatment was met. In the analysis, 88% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 82%.

Lipocine plans to submit a New Drug Application (NDA) for LPCN 1021 to the FDA in the second half of 2015.

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