On Monday, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), officially announced additional positive safety data from its ongoing LibiGel® Phase III clinical development program.
LibiGel® is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm. The product is being developed to treat women who suffer from female sexual dysfunction for which there is no clinically tested, FDA approved product, and do this with a drug that will be shown to be safe and effective, and affordable, both to develop and for women to use.
As we reported last Friday, the company was expected to unveil and report some unblinded data said to have been have been reviewed by an Independent Data Monitoring Committee (DMC) of the LibiGel Cardiovascular and Breast Cancer Safety Study.
The Phase III Cardiovascular and Breast Cancer Safety Study, is being conducted in addition to two LibiGel® Phase III efficacy trials. The Phase III efficacy trials of LibiGel® in the treatment of FSD are double-blind, placebocontrolled 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).
In an exclusive statement to BioMedReports, BioSante's Chief Exec. Officer and President, Stephen Simes stated:
This updated recommendation to continue with our Phase III clinical development safety study for LibiGel reinforces our high hopes that we can obtain FDA approval for LibiGel.
Furthermore, we are pleased to report that our efforts to enroll more than 2,400 women in our Cardiovascular and Breast Cancer Safety Study and approximately 500 surgically menopausal women each in our two Efficacy Trials have been proceeding as planned," Simes said. "This recruitment effort has been supported by an aggressive national advertising campaign funded in part by funds BioSante secured in last year’s financial transactions, including our merger with Cell Genesys. We remain confident that we can complete subject enrollment in these studies by the middle of this year and submit an NDA to the FDA by mid-2011.
A full, exclusive interview with BioSante's Stephen Simes is available at BioMedreports.
In a Phase II clinical trial, LibiGel® significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
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