BioSante: Study Generates Confidence For Future Treatment
By Len Zehr:
BioSante Pharmaceuticals’ (BPAX) successful pharmacokinetic study of its LibiGel (testosterone gel) treatment for female sexual dysfunction, specifically hypoactive sexual desire disorder (HSDD), is adding to the company’s overall confidence that its ongoing, long-term safety study also will be favorable, as will its efficacy trials.
“This pharmacokinetic study seems to corroborate our LibiGel safety study, which appears to show the safety of LibiGel versus placebo,” CEO Stephen M. Simes says in an exclusive interview with BioTuesdays. “What we’re seeing over time, although we remain blinded, is that there does not appear to be safety issues for LibiGel versus placebo in these women. In addition, the blood levels of free testosterone produced in this PK study support the potential efficacy of LibiGel.”
An independent Data Monitoring Committee has reviewed the unblinded safety data six times and recommended each time that the study keep going. A seventh review will be conducted in earlyComplete Story »