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FDA Panel Sends Safety Signal to Companies Making Sex Pills for Women

By Jim Edwards

Updated on: June 18, 2010 / 6:15 PM EDT / MoneyWatch

An FDA advisory panel gave a thumbs down to Boehringer Ingelheim's sex pill for women, flibanserin, today, and in doing so may have chilled research into drugs to boost female libido. While the FDA's panel voted 10-1 that it did not believe the drug was effective, it also voted 11-0 against the product on its safety record in trials.

That appears to set a high bar for safety in such drugs, because -- as you can see on page 39 onwards in this briefing document -- there were very few serious adverse events on the drug, and the FDA's advisers didn't pick out any of them for special concern.

Recall that while the FDA itself frequently follows advisory-panel recommendations, it's not bound by such decisions. In lopsided cases such as this one, however, the odds that the FDA would actually approve flibanserin approach zero.

Three companies are reportedly working on libido products for women, and two of them are looking at transdermal testosterone products:

BioSante will unveil results from its ongoing research at a conference on Sunday. The focus will be on those adverse event reports. That's a lot of pressure for BioSante and P&G, as P&G previously failed to get a testosterone product for women -- Intrinsa -- through the FDA, and it's hard to imagine a hormonal treatment having fewer side effects in women than an antidepressant like flibanserin.

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Image by Flickr user Qole Pejorian, CC.