BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the
Company plans to initiate two new LibiGel Phase III efficacy trials.
This decision is based on an extensive analysis of previous efficacy
data, consultation with key opinion leaders (KOLs) in female sexual
dysfunction, testosterone therapy and placebo effects, as well as a
meeting with the U.S. Food and Drug Administration (FDA). BioSante also
intends to continue the on-going LibiGel Phase III cardiovascular and
breast cancer safety study as per protocol. LibiGel (testosterone gel)
is in development for the treatment of female sexual dysfunction (FSD),
specifically, hypoactive sexual desire disorder (HSDD) in menopausal
women.
The protocol for the two new efficacy trials is in development, and
BioSante intends to provide additional trial design information and
timing of trial initiation once finalized. BioSante also intends to
apply for an FDA Special Protocol Assessment (SPA) agreement prior to
initiating the efficacy trials. Currently, it is expected that the
efficacy trials will include the same FDA-required efficacy endpoints as
prior Phase III efficacy trials: an increase in the number of satisfying
sexual events and sexual desire, and decreased distress associated with
low desire.
"We continue to believe that HSDD is an important unmet medical need for
women and that LibiGel can provide a meaningful treatment option," said
Stephen M. Simes, BioSante's president & chief executive officer. "In
addition, the ongoing LibiGel Phase III safety study, the largest
testosterone trial of its kind, has accumulated over 6,500 women-years
of data to support the safety of LibiGel. It is our intention to conduct
the primary analysis of the safety study in the second half of 2012."