The company is developing LibiGel as a treatment for female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
The enrollment of the patients has been stopped following the US Food and Drug Administration’s (FDA) consent depending on the sample size analysis by an independent Executive Committee.
As per a meeting conducted with the FDA, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante.
BioSante expects to submit the LibiGel NDA by the end of 2012.
BioSante Medical Affairs senior vice president Michael Snabes said formal completion of enrollment in the LibiGel safety study is based on the third sample size re-estimation analysis, and the first time that BioSante has been informed that the analysis indicates that enrollment should stop.
"The LibiGel safety study will continue as per protocol and the DMC will continue to take its periodic unblinded looks at all safety data," Snabes said.