BioSante has provided positive safety data in its ongoing LibiGel phase III clinical development program.
The phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study. It will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months.
The objective of the safety study is to show the relative safety of testosterone compared to placebo, in a number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.
In addition to the phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel phase III efficacy trials. The phase III efficacy trials of LibiGel in the treatment of FSD 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 SPA (special protocol assessment) agreement.
The company is now planning to submit NDA for the approval of LibiGel. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.
Stephen Simes, president and CEO of BioSante, said: “The cardiovascular safety data indicate that LibiGel, to date, has been shown to be safe. We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study.
We will continue to analyze blinded cardiac event data on a regular basis. LibiGel remains the pharmaceutical product in the US in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction (FSD),” he added.