LibiGel is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems (i.e. patches).
The LibiGel development program has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. BioSante has completed two Phase III LibiGel safety and efficacy trials and is conducting a Phase III cardiovascular event and breast cancer safety study. A new drug application (NDA) is planned to be submitted to the FDA by year-end 2012.
Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition to increasing sexual desire and activity and decreasing sexual distress, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood. The goal of testosterone treatment of women complaining of HSDD is to increase the serum testosterone towards the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder.
Development / Regulatory Status
Results of Phase II
Treatment with LibiGel in BioSante's Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238% 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.
Progress and Plans in Phase III
BioSante Canadian pharmacy has completed two Phase III LibiGel safety and efficacy trials to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease sexual distress. The two LibiGel Phase III safety and efficacy trials were double-blind, placebo-controlled trials of over 500 surgically menopausal women each for six months of treatment. In addition, BioSante is conducting a LibiGel Phase III cardiovascular event and breast cancer safety study that has completed enrollment of 3,656 women.