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by Robert MacKay, Monday, June 21, 2010 | Categories: Female Sexual Dysfunction | Flibanserin

As expected, the panel convened by the Federal Food and Drug Administration has voted against granting Boeringer Ingelheim’s Hypoactive Sexual Desire Disorder medication flibanserin approval.

The panel was chaired by Julia Johnson, the chief of obstetrics and gynaecology at the Medical School of the University of Massachusetts. She said in a statement that the drug was not sufficiently effective to outweigh the risks that it posed. The panel voted unanimously against it.

Boeringer said that Flibanserin, also known by its commercial name Girosa, controlled the levels of dopamine and norepinehrine, which both act on sexual desire. It also reduced the level of serotonin, which is thought to lower libido.

Analysis of two trials into the drug, which was originally developed as an anti-depressant, indicated that the difference the medication made to women’s sexual desire when compared to those taking the placebo was not convincing enough to demonstrate a statistically significant improvement in libido.

Though not required to do so by law, the FDA generally follows the recommendations of its panels.

Boehringer have vowed to continue to work on the treatment and have said they plan to work with the FDA to address the concerns raised by the advisory committee. They drew attention to the fact that the committee recognised that there was a significant unmet medical need for women suffering from Hypoactive Sexual Desire Disorder and they pointed out that there is still no FDA approved treatment for the condition.





 
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