BPAX- Biosante Pharmaceuticals

I think products like this will continue have a larger market as women live longer, more active lives. From what I've read, it's the best and most advanced contender for what it aims to do. They announced positive safety data from the Phase 3 trial in October, and should release another Phase 3 update by end of year 2009, which is in just a few weeks. The major concern was safety and seems like it not an issue this far.

They present at the OneMed Forum 1/12/-1/14/10. I'm hoping for a Phase 3 update then.

Briefly, they are developing:
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 concept behind the LibiGel® development program is intriguing – to develop a product to treat women who suffer from female sexual dysfunction for which there is no clinically tested, FDA approved product, and do this with a drug that will be shown to be safe and effective, and affordable, both to develop and for women to use. 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 hypoactive sexual desire disorder (HSDD). LibiGel could be the first FDA approved product to treat FSD, specifically HSDD in menopausal women.

Biosante Website


For some news regarding Phase 2 clinical trial results, which were really good,
"As previously announced by BioSante, treatment with LibiGel in a Phase II double-blind, placebo-controlled, clinical trial, conducted in the U.S., in surgically menopausal women distressed by their low sexual desire and activity, 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 percent versus baseline (p<0.0001);
this increase also was significant versus placebo (p<0.05), an average difference of 3.4 SSEs per four week period. 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.

Some info on a European competitor who has not managed anywhere near the statistical significance.
"Boehringer has been studying flibanserin in pre-menopausal women. Data, pooled from three Phase III studies, presented today from trials in Europe and the U.S., show a statistically significant improvement in satisfying sexual events (SSEs) compared to placebo, with an average difference of 0.70 SSEs per four week period. The results reported by Boehringer for
flibanserin are similar to data reported by Proctor & Gamble for their Intrinsa testosterone patch (now owned by Warner Chilcott). "

To sum it up, from one of their PR's linked above:
"The potential size of the market could exceed $2 billion a year in U.S. sales. BioSante intends to submit a new drug application for LibiGel to the FDA in the first half of 2011 for potential approval by the end of that year. In addition, Phase II studies in pre-menopausal women are ongoing for a potential future indication."