BioSante Pharmaceuticals, Inc. a pharmaceutical company developing products for the treatment of female sexual health, presented critical female sexual dysfunction market data at the ISSWSH (The International Society for the Study of Women's Sexual Health) annual meeting. The data presented include results of a survey of over 100 Obstetrician/Gynaecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).

There are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 per cent) reported that they prescribe off-label testosterone for women to treat FSD, however, these physicians are dissatisfied with the non-FDA approved, off-label alternatives. The physicians indicated that they hear an average of 37 unsolicited inquiries per month from women regarding sexual dysfunction. Nationally, it is estimated that 4.1 million off-label testosterone prescriptions are filled annually.

The physicians in the survey were asked their reaction to an unnamed therapeutic that fit LibiGel's profile. An overwhelming 94 percent responded favourably, as long as it is proven to be safe. To that end, BioSante is conducting a phase III multi-centre cardiovascular and breast cancer safety study. BioSante reported at the ISSWSH meeting that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated Cardio-Vascular (CV) events, with a lower than anticipated event rate of approximately 0.57 per cent. There have been eight breast cancers reported, a rate of approximately 0.27 per cent.

The survey, conducted independently for BioSante by Campbell Alliance Group, Inc., revealed sexual dysfunction to be one of the most common complaints received in these doctors' offices. The physicians described themselves as dissatisfied with the current lack of therapeutic options for HSDD, a loss of libido or sexual desire.

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 up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved Special Protocol Assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.

In a phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 per cent 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 is a specialty pharmaceutical company focused on developing products for female sexual health and oncology and its lead products include LibiGel (transdermal testosterone gel) for the treatment of Female Sexual Dysfunction (FSD) which is in phase III clinical development under a US Food and Drug Administration (FDA) Special Protocol Assessment.