BioSante Pharmaceuticals, Inc. announced that enrollment of subjects in the first of two pivotal phase III LibiGel (testosterone gel) safety and efficacy trial has been completed. The efficacy trials are being conducted under an FDA-approved Special Protocol Assessment (SPA) agreement. LibiGel is in development for the treatment of Female Sexual Dysfunction (FSD), specifically, Hypoactive Sexual Desire Disorder (HSDD) in menopausal women, for which there is no FDA-approved product.

“This is an important milestone for BioSante. This achievement represents a key positive step toward completing the LibiGel phase III clinical development programme. To date, we have a combined enrollment in our three LibiGel phase III clinical studies of approximately 4,000 women and we anticipate announcing completion of enrollment in the second efficacy trial very soon,” said Joanne Zborowski, BioSante's vice president of clinical development.

LibiGel is a testosterone gel in phase III clinical development for the treatment of women who suffer from Female Sexual Dysfunction (FSD). The on-going phase III efficacy trials are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each.

In a phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group.

In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

BioSante also is conducting a phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-centre, cardiovascular (CV) events and breast cancer study that has enrolled 2,869 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.

The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes.

The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. To date, there have been 17 adjudicated cardiovascular (CV) events, a lower than anticipated rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.