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Oral Testosterone Replacement Therapy Meets Phase III Goals
Positive results have been reported from an ongoing pivotal phase III trial evaluating the efficacy and safety of LPCN 1021 (Lipocine Inc.), an oral testosterone product, in hypogonadal men with low testosterone levels. The study demonstrated positive results with respect to the primary efficacy endpoint, with no serious adverse events.
A new drug application is expected to be submitted to the FDA in the second half of 2015.The Study of Oral Androgen Replacement (SOAR) is a randomized, open-label, parallel-group, active-controlled trial of oral testosterone replacement therapy in hypogonadal men with low testosterone levels (less than 300 ng/dL). A total of 315 subjects were randomly assigned to receive LPCN 1021 (n = 210) or an active control (n = 105) for 52 weeks. The active control was included for safety assessments.The subjects treated with LPCN 1021 were started at 225 mg testosterone undecanoate (TU) (equivalent to approximately 142 mg of testosterone) twice daily (BID) with a standard meal and were then dose-titrated, if needed, up to 300 mg TU BID or down to 150 mg TU BID, based on serum testosterone levels measured during weeks 3 and 7. The subjects’ mean age was approximately 53 years, and most (approximately 91%) were less than 65 years of age.
The primary efficacy endpoint was the percentage of subjects with an average 24-hour serum testosterone concentration (Cavg) within the normal range (300 to 1,140 ng/dL) after 13 weeks of treatment. The FDA guidelines for primary efficacy success are that at least 75% of the subjects receiving active treatment achieve a testosterone Cavg within the normal range, and that the lower bound of the 95% confidence interval (CI) must be greater than 65%.
LPCN 1021 successfully met the FDA primary efficacy guidelines. In the efficacy population set (EPS) analysis, 88% of the subjects receiving active treatment achieved a testosterone Cavg within the normal range, with a CI of 82%. In addition, a sensitivity analysis reaffirmed the finding that LPCN 1021 successfully met the FDA primary efficacy guidelines as 80% of the subjects on active treatment achieved a testosterone Cavg within the normal range, with a CI of 74%.
Other highlights of the efficacy results include:
- The mean Cavg was 447 ng/dL, with a coefficient of variance of 37%.
- Less than 12% of the subjects were outside the testosterone Cavg normal range at the final dose.
- Most of the subjects (85%) arrived at the final dose with no more than one titration.
- About half of the subjects (51%) received a final dosage of 225 mg BID.
Source: Lipocine Inc.; September 24, 2014.