Advisory Committee to Discuss Sprout Pharmaceutical's Drug ‘Flibanserin’
A drug nicknamed ‘female Viagra’ will be discussed for the third time at a meeting of an advisory committee to US regulators on Thursday.
If the US Food and Drug Administration (FDA) approves the drug, it will be the first drug in the market to boost female libido. So far two attempts to bring the drug to market have failed in 2010 and 2013. As per experts, the drug has several loopholes that need to be looked after.
Flibanserin, aimed at pre-menopausal women, can have significant side-effects, including nausea, dizziness and sleepiness, said experts.
On Thursday, the committee will hear the evidences from clinical studies of the drug and from experts, both in favor and against it.
It will be decided at the end of the day whether FDA should approve the drug, a decision that is non-binding but is usually followed by the regulatory agency.
Flibanserin, after being initially rejected by FDA, was sold by its developer, the German laboratory Boehringer Ingelheim, to a US firm called Sprout Pharmaceuticals.
In its latest attempt for the drug’s approval, Sprout Pharmaceuticals is presenting research that shows the medication does not affect women`s ability to drive.
The documents on the FDA website describe a previous study of the drug, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.
The aphrodisiac properties of flibanserin were discovered accidentally when it was tested as an anti-depressant, the drug-maker says.