BioSante Pharmaceuticals, Inc. announced that it successfully has completed and reached an additional agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its LibiGel (transdermal testosterone gel) programme in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in "naturally" menopausal women. Previously, BioSante received an SPA for LibiGel's use in "surgically" menopausal women.
"In addition to being another major milestone for BioSante, receiving a second SPA for naturally menopausal women is a significant development for the entire FSD category," said Stephen M Simes, BioSanteís president & CEO. "This action by the FDA once again confirms FDA's position that FSD and HSDD are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options. Importantly, the FDA now officially has opined on this position for both surgically and naturally menopausal women."
"With our two SPAs and meeting minutes received from FDA, we have a clearly defined, reasonable and feasible LibiGel development path that can lead to the approval of LibiGel to provide potential benefit for an even broader population of menopausal women. Since no pharmaceutical product is approved for the treatment of FSD or HSDD in the US, LibiGel, if approved by the FDA, will address a truly unserved market. BioSante is committed to the development of LibiGel, which ultimately could be the first product approved by the FDA for this treatment in the US"
In addition to the LibiGel Phase III safety and efficacy trials, two of which are in progress, BioSante is enrolling in a Phase III cardiovascular safety study of LibiGel. Pursuant to a written agreement with the FDA, this one safety study will serve as the basis of safety for both surgically and naturally menopausal women. The safety study is a randomized, double-blind, placebo-controlled, multi-centre, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of the 12 months, BioSante intends to submit a LibiGel New Drug Application (NDA) for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial 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.
LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.