Antidepressant (5-HT1a agonist and 5-HT2 antagonist); female sexual enhancement
A new drug designed to boost sexual desire in women is controversial for some and eagerly awaited by others, but it's hit a potentially serious snag. The drug didn't boost women's desire any more than a placebo in two clinical trials. The Food and Drug Administration posted the clinical trial results on its website today in advance of a committee meeting on Friday, when a panel of experts will vote whether or not to recommend approval of the drug called flibanserin. Although there was a slight increase in the number of sexually satisfying events flibanserin users had each month,
Flibanserine is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report a 0.5 increase compared to placebo in the number of times they had “satisfying sexual events”.In those on flibanserin it rose from 2.8 to 4.5 times a month while women receiving placebo reported also an increase of “satisfying sexual events” from 2.7 to 3.7 times a month.The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.
The effectiveness of flibanserine was evaluated in three phase 3 clinical trials. Each of the three trials had two co-primary endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire. Each of the 3 trials also had a secondary endpoint that measured distress related to sexual desire. All three trials showed that flibanserin produced an increase in the number of SSEs and reduced distress related to sexual desire. The first two trials used an electronic diary to measure sexual desire, and did not find an increase. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and an increase was observed using this latter measure. The FSFI was used as the co-primary endpoint for
sexual desire in the third trial, and again showed a statistically significant increase
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Qingdao Sigma Chemical Co., Ltd.is a global chemical industry manufacturers and suppliers of pharmaceuticals and intermediates, food and feed additives, herbal extracts, agrochemicals and fine chemicals etc.
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