BioSante Reports Positive LibiGel Safety Data in Phase III Clinical Program
LibiGel is a testosterone gel Phase III in 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.
LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
The LibiGel Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, CV events and breast cancer study that will enroll between 2,500 and 4,000 women, exposed to LibiGel or placebo for 12 months. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years. The first decision point as to whether enrollment is complete or needs to continue will occur early in the fourth quarter 2010.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also will be tracked over the course of the study.
Michael Snabes, BioSante’s vice president of clinical development, said: "To date, there have been only seven adjudicated CV events and only four diagnoses of breast cancer reported in the study population. If testosterone increased CV disease, the CV event rate would be expected to be higher in the women enrolled since as per the protocol, the study subjects are at the higher end of cardiovascular risk for the intended treatment population.
"With this favorable DMC recommendation, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD."
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