FDA Panel Endorses ‘Female Viagra’ Pill

By Cheri Cheng - 05 Jun '15 11:31AM

The advisory panel to the U.S. Food and Drug Administration (FDA) has voted in favor of approving flibanseri, dubbed the "female Viagra" pill, on Thursday.

The panel, which voted 18-6, noted that if the FDA approves the drug, it should be done with certain conditions, which include proper warning labels and education about the side effects.

The drug has been rejected twice over the past few years. In the earlier trials, researchers found that the drug can cause fainting, nausea, dizziness, sleepiness and low blood pressure. The FDA had decided that the benefits did not outweigh the cons during that time.

In recent clinical trials, which were carried out by Sprout Pharmaceuticals, women with the average age of 36 took the drug for five months and reported that their sexual desire increased while distress decreased. Women also reported an increase in "sexually satisfying events." The panel noted that the benefits were "moderate."

Flibanseri, which would be sold as Addyi, treats hypoactive sexual desire disorder (HSDD) by changing the balance of brain chemicals, dopamine, norepinephrine and serotonin. HSDD is described as a lack of sexual desire that can lead to emotional distress. Only premenopausal women suffering from this disorder would be allowed to take the drug.

There are currently no drugs on the market for women who deal with libido issues.

The FDA tends to follow the advise of the panel but is not required to do so.

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