Female Viagra: Flibanserin Approval Backed by Federal Advisory Panel

A federal advisory panel has urged the Food and Drug Administration (FDA) to approve Sprout Pharmaceuticals’ flibanserin, nicknamed the “female Viagra”.

The experts backed flibanserin, but said it must carry warnings about strong possible side effects including fainting and tiredness.

By a vote of 18-6, the advisory committee to the FDA favored approval of the drug for women whose lack of s**ual 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 final decision now moves to the FDA.

Now the drug could be approved by August 18, the FDA’s deadline for making a decision.

The FDA has rejected the drug twice since 2010 but it usually follows the advice of its experts.

The agency has previously approved Viagra for men in 1999.

The move was immediately hailed by some women’s organizations. Their controversial campaign by 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 while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.

According to experts, the drug has “modest results”, however, Dr. Julia Heiman of the Kinsey Institute at Indiana University said: “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”

One patient who received the drug explained its appeal.

“For us, flibanserin is a relationship-saving and life-changing drug,” said Amanda Parrish.

Some criticized the campaign as providing cover for a drug with marginal effects.

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

If approved, flibanserin will be aimed at pre-menopausal women.