Government health officials who advise the Food and Drug Administration (FDA) have given the “female Viagra” drug their backing and recommended that the FDA approve it, but with safety restrictions and conditions attached.
The panel voted 18-6 in favor of the drug, called flibanserin, designed to boost the sexual desire of women who have lost their libido. It has so far been rejected twice by the FDA, once in 2010 and again in 2013, due to worries over side effects. But other groups claim that the real barrier to getting the pill approved is one of inherent sexism.
The main concern over the drug's use (and the reason it’s been stalled for the past five years) is one of safety. The FDA claims that this is the real issue and not some underlying bias. They say that the side effects, such as dizziness, nausea and low blood pressure, simply outweigh any benefits derived from it. They highlight the fact that some women had to drop out of the trial due to such extreme negative effects.
Other women involved in the clinical trial of the “little pink pill” have, however, sung its praises. Some of these 11,000 women gave testimony at the hearing, explaining to the panel how psychologically and emotionally damaging it was to lose their sex drive, a condition called Hypoactive Sexual Desire Disorder (HSDD). They explained how the pill was able to give them relief, and in some cases saved their relationships.
The manufacturer of the drug, Sprout Pharmaceuticals, who bought it off the original developer after the first FDA rejection in 2010, says that the double-blind trials prove that flibanserin works better than a placebo in boosting women’s libidos, increasing the number of “sexually satisfying events,” and reducing depression associated with HSDD.
Although it has been dubbed the “female Viagra,” this is really a misnomer as it works in a completely different way. While Viagra works by simply increasing the blood flow, allowing men who already want to perform to stand to attention, flibanserin actually alters the brain's chemistry. It influences the levels of dopamine and serotonin in the brain, hormones known to play a role in sexual desire and motivation.
Sprout claims that after 24 weeks, between 46–60% of women had experienced beneficial results from the drug. But some of the committee did point out that when the placebo effect is taken into account, the drug itself only has an effect on around 10% of women.
Some women’s advocacy groups argue that while there are around 26 different drugs available for and marketed at men with erectile dysfunction (ED), there is not a single drug so far aimed at women’s sexual needs. They say that the FDA has repeatedly rejected flibanserin due to an inherently sexist society. Other have pointed out, however, that there are not 26 different drugs, but 26 different brands, and in actual fact there are only around 6 separate drugs used to treat ED. But this is still 6 more than there are for women.
The committee concluded that as women currently have nothing on the market to help them with low sexual desire, the drug should be made available even if the benefits are moderate, so long as it carries proper warnings and the women are educated about the possible side effects. The FDA often follows advice given by the committee, though not always, and if they do give the green light to flibanserin, it should happen by the end of summer 2015.
2