US Food And Drug Administration advisory panel recommends approval of female Viagra flibanserin
The drug has already been rejected twice by the FDA due to dizziness, nausea, fainting and low blood pressure
Following a major campaign by American women, an advisory panel of the US Food and Drug Administration has recommended that a new pill referred to as female Viagra be approved — with conditions.
The committee voted 18-6 to recommend that the FDA approve flibanserin, a drug designed to boost low sexual desire of otherwise healthy women, reports NPR. The FDA, whose decision is expected the end of the summer, doesn't always follow the recommendations of its advisory panel.
The drug has already been rejected twice by the FDA, with officials citing its effects of dizziness, nausea, fainting and low blood pressure as outweighing a moderate increase in sex drive. Officials are also worried about the drug's interaction with other drugs -- particularly with birth control pills and alcohol -- and its potential to increase accidents like car crashes and falls.
Some advocacy groups such as the National Organization for Women say the FDA is holding the drug to far higher standards than what was demanded from Viagra and Cialis for male sexual problems.
Drug worked better than a placebo, say developers
An online petition campaign and moving testimony from women who suffer from low sexual desire have helped convinced committee members to support approval of flibanserin, provided it has proper warning labels. Women currently have no other options. There are currently some 25 drugs for men with low sex drive on the market, but not a single one for women.
Drug developer Sprout Pharmaceuticals presented the results of a series of clinical trials to the committee that showed the drug worked better than a placebo to boost women's sexual desire, increased the number of sexually satisfying events and lowered women's distress at the loss of their libido.
Some committee members were worried about a two-year cancer study that found an increased risk in breast cancer tumours in mice that were given four times the therapeutic dose. Sprout representatives said that increased tumours in one sex in animal studies have not been found to predict cancers in humans.
Waiting in the wings are increasingly frustrated and American women who have been accusing the FDA of gender bias in its drug choices. "It's time to level the playing field when it comes to the treatment of women's sexual dysfunction," declares the web site of Even the Score, a campaign to get the pill approved.
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