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Female Answer To Viagra Just Can't Stand Up To Testing Says FDA
Health

Sad news for the world of gettin-it-on today: A drug that had been intended as a female analog to Viagra has not only not shown promise in tests, but has actually demonstrated some quite non-sexy side effects.

According to documents released regarding the experimental drug flibanserin, women who tested the pill reported depression, fainting, fatigue and other problems. Additionally, the FDA says that the drug's tolerability was "only moderate."

An FDA panel is to meet tomorrow to discuss whether or not to approve flibanserin (proposed retail name: Girosa) as a prescription drug for treating premenopausal women with hypoactive sexual desire disorder, aka a lack of sex drive.

But the results of two sets of clinical trials have given the FDA concerns about the drug's efficacy.

According to the FDA, while the drug increased the number of sexually satisfying experiences it failed to improve sexual desire.

Wrote the reviewers in their notes for the panel:
"Therefore, neither study met the agreed-upon criteria for success in establishing [efficacy]."

As mentioned above, many trial subjects experienced fatigue, drowsiness and other side effects. Thus, the FDA isn't sure if just slapping a warning label on the drug would be enough. "It is not clear if labeling alone will be sufficient to alert women to the numerous drug interactions that exist with flibanserin," they said.

Regardless, the maker of the drug, German pharma biggie Boehringer Ingelheim, thinks they've got this one in the bag.

Says some guy from Boehringer whose medicine cabinet probably has all sorts of cool bottles in it, "We are confident in our data that flibanserin's safety and efficacy has been demonstrated."

The panel's recommendation isn't the final say on a drug's approval, though it is a very good barometer for whether or not the drug company should start ordering party hats.

The bigger question involved with this -- and all "female Viagras" -- is that, unlike Viagra, which fixes a mechanical issue in male patients, these drugs are attempting to deal with something perceived to be more mental or psychological in nature.

So do you think a drug that works on this level would be as successful in terms of sales as Viagra has been for Pfizer?

'Female Viagra' pill a failure in tests, FDA officials say

Posted on Friday, June 18, 2010 @ 06:45:30 UTC by NB
 
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