LibiGel may be the first FDA approved product to treat HSDD in menopausal women
December 20, 2015
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.
SOURCE BioSante Pharmaceuticals, Inc.