FDA Panel Backs Female Libido Drug - Drug Discovery and Development

On Thursday, the panel of advisers to the U.S. Food and Drug Administration voted 18 to 6 to recommend that the agency approve flibanserin— nicknamed ‘women’s Viagra’ — as the first prescription treatment to boost libido in women. The contingency? That the drug’s manufacturer, Sprout Pharmaceutical, develops measures to limit safety risks. Flibanserin’s risks include low blood pressure and fainting.

“I have serious, serious, serious safety concerns,” said Dr. Walid Gellad of the University of Pittsburgh, a panel member who still voted to recommend approval, reports NBC News. “The benefits are modest, maybe less than modest. But I think that puts it in good company with other approved drugs.”

Flibanserin, a pink pill that would be taken daily at bedtime, would be approved to treat hypoactive sexual desire disorder.

The positive recommendation is a major victory for a drug that’s been twice rejected by the FDA since 2010 due to its minimal benefits and safety concerns.