BioSante announced positive safety data from Phase 3 trials of LibiGel (testosterone) for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women; the company announced that the independent Data Monitoring Committee (DMC) has completed the ninth unblinded review of the LibiGel Phase 3 cardiovascular (CV) events and breast cancer safety study and has recommended that the LibiGel study should continue as per the FDA-agreed protocol, without modifications.
The Phase 3 LibiGel safety study was a randomized, double-blind, placebo-controlled, multi-center study. The LibiGel safety study tracked a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke, in women ≥50 years of age and suffering from at least two CV risk factors (eg, hypertension and diabetes).
The objective of the safety study was to show the relative safety of testosterone compared to placebo in the number of cardiovascular (CV) events, as well as the incidence of breast cancer. At the time of this DMC review, there have been 53 adjudicated CV events, with a lower than anticipated event rate of approximately 0.72%. In the same population of subjects, there have been 27 breast cancers reported, a rate of approximately 0.37%, which is in line with the expected rate based on the ages of the subjects enrolled in the study.
Given this latest review during which no specific or general safety issues were raised, and after extensive consideration, BioSante also announced the conclusion of the LibiGel Phase 3 safety study effective immediately. Prior to the initiation of the LibiGel safety study in 2008, the FDA advised BioSante that subjects in the cardiovascular event and breast cancer safety study had to have a minimum average exposure in the safety study of 12 months prior to submitting a LibiGel new drug application (NDA), and prior to a potential FDA approval of LibiGel. At this time, subjects have been in this study for an average time of 24.5 months; more than 3,200 subjects have been in the study for more than one year and over 1,700 subjects have been enrolled for more than two years. With this ninth positive unblinded review of the study by the DMC, and over 7,300 women-years of exposure, BioSante believes that adequate safety data of LibiGel use in menopausal women has been obtained.
LibiGel is a topical testosterone gel that is absorbed through the skin and delivers testosterone to the bloodstream over time.
For more information, call (847) 478-0500 or visit www.biosantepharma.com.