(By Balaseshan) Biosante Pharmaceuticals Inc. (NASDAQ:BPAX), a specialty pharmaceutical company, said it intends to begin two new LibiGel Phase 3 efficacy trials - one for the treatment of female sexual dysfunction and another for cardiovascular and breast cancer safety study.
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 plans to continue the on-going LibiGel Phase 3 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 previous Phase 3 efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire.
As announced on December 14, 2011, the company's previous LibiGel Phase 3 efficacy trials indicated that LibiGel increased satisfying sexual events and sexual desire and decreased distress.
However, the placebo response in the two previous efficacy trials was greater than expected; therefore, LibiGel's results were not shown to be statistically different from placebo. BioSante is committed to ensuring that the design of the new Phase 3 efficacy trials addresses the higher than expected placebo response observed in the prior trials.
BPAX closed Friday's regular session down 1.54% at $2.56. The stock has been trading between $2.01 and $24.12 for the past 52 weeks.