Boehringer Ingelheim's 'female Viagra' flibanserin fails to meet efficacy endpoints, say US FDA reviewers

According to documents released yesterday, ahead of a US Food and Drug Administration advisory review panel meeting on Friday (June 18), agency reviewers said that independent German drug major Boehringer Ingelheim's flibanserin, a drug directed for low female sex drive, failed to meet one of two co-primary efficacy endpoints.

The FDA reviewers concluded that, 'in premenopausal women with HSDD, flibanserin 100mg qhs was associated with significant improvements in the number of SSE, sexual desire (measured by FSFI desire), distress associated with sexual dysfunction (measured by FSDS-R and Item 13) and sexual function (measured by FSFI) but did not significantly improve eDiary desire score, compared with placebo. The SSE primary endpoint was statistically significant as per the formal statistical inference procedures, but the other primary endpoint, eDiary sexual desire score was not; therefore, the interpretation of significance on secondary endpoints should be regarded as nominal significance.'

Put simply, neither Boehringer Ingelheim study met agreed-upon criteria for efficacy of flibanserin for treating low sex drive in women. Moreover, the FDA staffers said that it is not clear if data from flibanserin are generalizable to target population.