Keywords: Boehringer Ingelheim, Flibanserin, Female sexual arousel, Research
Boehringer Ingelheim’s “female Viagra” flibanserin fails to meet efficacy endpoints, say US FDA reviewers
Article | 17 June 2010
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. Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
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