Boston, MA 09/25/2014 (wallstreetpr) – A specialty pharmaceutical company, Lipocine Inc (NASDAQ:LPCN), disclosed a favorable top line efficacy results of its ongoing Study of Oral Androgen Replace or SOAR pivotal final stage clinical trial evaluating safety and efficacy of LPCN 1021 for the treatment of Oral Testosterone in hypogonadal men having a low testosterone.
NDA Next Year
Lipocine Inc (NASDAQ:LPCN) said that overall the trial displayed favorable results in connection with the study’s primary efficacy endpoint since there were no serious adverse events, its statement indicated. As a result, Lipocine said that it anticipates filing a New Drug Application or NDA with the Food and Drug Administration or the FDA during the second six-month period of the next year.
SOAR Phase 3 Study
The specialty pharmaceutical company said that SOAR was an open-label, randomized, active-controlled, parallel-group final stage trial of oral Testosterone Replacement Therapy or TRT in hypogonadal men having a low testosterone. In all, 315 subjects with 40 active sites were assigned for the trial. Of this, 210 were randomized to the drug candidate LPCN 1021 while 105 were randomized to the active control, which means one-year treatment.
Lipocine said that safety assessment was also included in the active control. The company indicated that the drug candidate subjects commenced at 225 mg testosterone undecanoate twice a day with a standard meal. The dosage then titrated, if required, to a maximum of 300 mg.
The company said that an analysis of primary statistics was conducted using the Efficacy Population Set or EPS, which was described as subjects randomized into the trial. It has also conducted more analysis with the help of safety set.
Results
Lipocine Inc (NASDAQ:LPCN) said that the results met primary efficacy endpoint by restoring testosterone levels successfully to the regular range in 88% of the subjects while lower cap of the 95% confidence gap was 82%. Significantly 85 of the subjects were able to reach final dose with only one dose titration. Majority of the subjects finished on 225 mg.
The company’s Chairman, President and Chief Executive Officer, Mahesh Patel, said that the company was looking forward to providing additional safety results from its ongoing trial.
