An advisory committee to the Food and Drug Administration (FDA) has recommended the approval of the drug, flibanserin, for premenopausal women who are distressed by a lack of sexual desire. The little pink pill has been hailed as “Viagra for women”.
But it’s not like Viagra. Viagra targets the hydraulics of erectile dysfunction. The mechanism of flibanserin is to increase low sexual desire by acting on dopamine and serotonin receptors in the brain, much like an antidepressant. In fact, flibanserin has been unsuccessfully trialled as an antidepressant.
The recommendation has been welcomed as a win for sexual equality by a controversial advocacy group called Even the Score which is backed by Sprout Pharmaceuticals, the developers of the drug. The campaigners argued that because men have Viagra, it’s only fair that women should have access to a similar medical solution to their sexual problems.
Others question whether “hypoactive sexual desire disorder” exists and whether low sexual desire in women can actually be “fixed” by a drug. Is it helpful to medicalise low sexual desire among women when fluctuations in sexual desire over the life cycle, and in response to life events, are perfectly normal? There are also concerns about the impact on gender relations, increased pressure on women to enjoy and initiate sex, and the potential coercive use of the drug.
This is the third time that the advisory committee has considered whether to recommend the approval of flibanserin. Why did it get through this time? Supporters of the Even the Score campaign packed the advisory committee meeting room in a move orchestrated to create the perception of unmet and urgent need for the drug. It is this perception of need that swayed the committee’s decision, not robust evidence of effectiveness in combination with a reassuring safety profile. In fact, flibanserin has been described as a “mediocre aphrodisiac with scary side effects”.
The evidence presented to the committee about the effectiveness of flibanserin was not compelling. Compared to a placebo, flibanserin increased the reported number of “sexually satisfying events” for women by around one event per month, with a very tiny increase in women’s perceived sexual desire. The risks associated with the use of flibanserin are significant enough to be concerning – low blood pressure, fainting, nausea and dizziness – and were higher when women drank alcohol or used the contraceptive pill, both common behaviours among sexually active women.
The question now is whether flibanserin will be approved by the FDA. If it is approved, to what extent will there be real benefits for women? The deadline for a decision is the 18th August. Watch this space.