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.