BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a pharmaceutical company developing products for the treatment of female sexual health, today announced results of a survey of over 100 Obstetrician/Gynecologists 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). The multiple surveys, 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.
Stephen M. Simes, president and CEO of BioSante, said, "The need for an FDA-approved treatment to cope with this condition is accepted by an astonishing over 90 percent of the doctors surveyed by Campbell. It has been more than a decade since the FDA approved Viagra for the treatment of male sexual dysfunction; it is time to provide women and their healthcare providers with a safe and effective option."
BioSante is developing LibiGel®, a testosterone gel, for treatment of HSDD in menopausal women. LibiGel is currently in three Phase III clinical studies to prove its safety and efficacy.
The doctors surveyed indicated that if their patients are not experiencing relationship problems or some other condition that could suppress their desire for sex, therapeutic options should be considered. However, there are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 percent) 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. Nationally, it is estimated that 4.1 million of such off-label prescriptions are filled annually.
The doctors were asked their reactions to an unnamed therapeutic that fit LibiGel's profile. An overwhelming percentage (94%) responded favorably, as long as it is proven to be safe. BioSante is conducting a Phase III multicenter cardiovascular and breast cancer safety study. Based on approximately 2,800 women in the safety study for an average of approximately 11.5 months each, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.52 percent, compared to an expected rate of approximately two percent and only eight diagnoses of breast cancer, a rate of approximately 0.30 percent, compared to an expected rate of approximately 0.35 percent, after approximately 2,700 women-years of exposure in the study.
According to Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, "If testosterone increased the incidence of cardiovascular events, we would see a higher rate of such events, especially since the study subjects are at the higher end of cardiovascular risk for the intended treatment population. The expected rate of cardiovascular events in the women in the study is approximately two percent. Based on the safety seen to date, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women." BioSante anticipates the submission of a new drug application for LibiGel in 2011 and a product launch in 2012.
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