BioSante Pharmaceuticals, Inc., a drug development company that uses nanotechnology to develop their products, have announced that it has successfully completed validation studies required as part of the clinical development program of LibiGel for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD). The data will be presented today at the annual meeting of the North American Menopause Society in Dallas, Texas.
As per U.S. Food and Drug Administration (FDA) published guidance for Patient Reported Outcome (PRO) studies, the pivotal efficacy studies of LibiGel require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. BioSante has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire. BioSante worked with FDA’s Division of Reproductive and Urologic Products and followed the FDA’s guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of Sexual Events and Desire (ISED) was able to differentiate between women with HSDD and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p < 0.001).
“We are pleased with these results,” said Stephen M. Simes, BioSante’s president & CEO. “Patient reported outcome tools are difficult to validate and these results allow us to confidently move forward with the pivotal efficacy studies for the development and potential approval of LibiGel in the treatment of female sexual dysfunction, an underserved market in the U.S. since no pharmaceutical product is approved for its treatment. BioSante is committed to the development of LibiGel for FSD which may ultimately be the first product approved by the FDA for this treatment in the U.S.”
The Phase III efficacy trials of LibiGel in the treatment of FSD, one of which has been initiated, 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 trial already initiated is being conducted under a Phase III protocol reviewed by and on file with the FDA and in which written FDA comments have been received and incorporated. BioSante hopes to initiate the second Phase III efficacy trial by early 2008.
In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. A new drug application (NDA) can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval, BioSante will continue to follow the women enrolled in the study for an additional four years.
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.