FDA experts unanimously reject Boehringer’s female libido pill

Undercut by a harsh regulatory assessment on both safety and efficacy, Boehringer Ingelheim's female libido pill was handed a decisive rejection by an expert FDA panel on Friday. The experts voted unanimously that Boehringer had not demonstrated an acceptable risk/benefit profile for the drug, setting the stage for an all-but-certain formal rejection by the FDA. FDA staffers had already concluded that the efficacy data on flibanserin's ability to stimulate women's sexual desire was...

FDA staffers raise doubts about Boehringer’s female libido drug

Just ahead of a June 18 FDA panel review, the FDA has released a staff review of Boehringer Ingelheim's sexual desire drug flibanserin, saying it may not be either safe or effective. Unlike male sex drugs, which are designed to stimulate the penis, Boehringer's therapy is aimed at the brain. The agency staffers concluded that the drug "failed to demonstrate a statistically significant improvement" and was linked to a range of side effects including appendicitis, depression, dizziness and loss...

FDA panel review looms for controversial libido drug

The first time researchers studied flibanserin, they thought they had a potential new depression therapy on their hands. That approach failed. But now Boehringer Ingelheim is preparing to make the case to a panel of FDA experts that the drug should be approved to boost women's libido, seeking an approval for a 'pink Viagra' that could earn up to $2 billion a year. The agency's views have yet to be heard, but there's already plenty of debate in women's health circles about the prospects of a new...