BioSante Says LibiGel Safety Study Will Continue

LINCOLNSHIRE, Ill. (AP) — BioSante Pharmaceuticals Inc. said a clinical study indicates its drug LibiGel does not increase heart problems and death in high-risk women.

LibiGel is a testosterone gel applied to the skin, and BioSante is testing it as a treatment for sexual dysfunction in women. It is running tests to evaluate LibiGel's effectiveness, and is also conducting a late-stage trial to test the product's safety. The company said the trial will continue because there were no deaths, and only five reported heart problems.

The news sent BioSante shares surging 55 cents, or 30.1 percent, to $2.33 in midday trading.

In the safety study, BioSante is testing LibiGel on women over 50 with risks such as high blood pressure and diabetes. The company intends to find out if using LibiGel increases the risk of breast cancer, heart attack, stroke, or death from heart ailments.

About 1,250 women are enrolled in the study, and the company plans to involve 2,400 to 3,100 women in the trial. They will be treated with either LibiGel or a placebo for one year.

LibiGel is designed to be rubbed into the upper arm once per day, and gradually release testosterone into the bloodstream. BioSante expects to file for Food and Drug Administration approval by mid-2011, and says it will continue to monitor women in the safety study for four years after that.