Lipocine Inc. Announces First Patient Dosed In Phase 3 Study For Oral Testosterone Replacement Therapy
2/10/2014 9:31:00 AM
SALT LAKE CITY, Feb. 10, 2014 (GLOBE NEWSWIRE) -- Lipocine Inc. (OTCQB:LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in its Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study. The trial is designed to evaluate the safety and efficacy of LPCN 1021, an oral testosterone replacement therapy, in hypogonadal men with low testosterone (Low T; www.lowtstudy.com). Approximately 300 patients are expected to be enrolled in multiple sites in the United States. The company expects to report top-line efficacy data for the trial in the second half of 2014 with a New Drug Application ("NDA") filing with the U.S. Food and Drug Administration (FDA) anticipated in the second half of 2015.
Help employers find you! Check out all the jobs and post your resume.
comments powered by