If at first you don't succeed at a late-stage development program, try, try again. That's what BioSante Pharmaceuticals ($BPAX) plans to do with LibiGel, in development for female sexual dysfunction. The biotech got walloped in December when it announced that a pair of Phase III studies had been scuttled by an unexpected placebo response. Now it says it will design and execute on two more studies to see if it can grab the elusive primary endpoint.
The company was forced to ax a quarter of its staff after the initial clinical setbacks. BioSante announced today that it will stay focused on the initial, FDA required endpoints: an increase "in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire." And the developer says it will provide more details on the trial design after they're developed.
"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 and CEO. "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."
- here's the press release