Drug to treat lack of sexual desire in women edges closer to approval

A US federal advisory panel recommended approval of what would become the first drug to treat a lack of sexual desire in women after an intense lobbying campaign. The move was immediately hailed by some women's organisations as a step toward sexual equality by, in effect, giving women their counterpart to Viagra, the widely prescribed drug for male erectile dysfunction.

By a vote of 18-6, the advisory committee to the Food and Drug Administration favored approval of the drug, flibanserin, for women whose lack of sexual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug.

Doctors might be required, for instance, to inform patients of potential side effects – like low blood pressure, fainting, nausea and dizziness – and physicians might have to become certified to prescribe the drug.

The controversial campaign by some women's groups to win federal approval was waged under the banner Even the Score, which accused the FDA of gender bias because it had approved Viagra and other drugs to help men have sex while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.

That campaign, which packed the advisory committee meeting room with the drug’s supporters, plus some new data from clinical trials, apparently helped tip the balance for flibanserin, which has been rejected twice by the FDA.

The first time, in 2010, came after a similar advisory committee had voted unanimously against approval.

Now the drug could be approved by August 18th, the FDA’s deadline for making a decision. Some other women’s groups and individuals, however, have criticised Even the Score as a distasteful attempt to use women’s rights as a cover to get an undeserving drug approved.

“To approve this drug will set the worst kind of precedent – that companies which spend enough money can force the FDA to approve useless or dangerous drugs,” Dr Adriane Fugh-Berman of Georgetown University told the committee Thursday.

She is the director of PharmedOut, a project that questions the influence of drug companies on the practice of medicine. – Copyright New York Times 2015