FDA advisory group gives its go ahead to the drug for women with low sex drives
A U.S. Food and Drug Administration advisory panel gave its stamp of approval to a first-of-its-kind drug to treat lagging sexual desire in women–albeit with some warnings.
The advisory committee voted 18 to 6 to approve the drug, flibanserin, as long as steps are taken to minimize the risk of side effects.
The little pink pill–a fitting companion to Viagra’s memorable blue hue– would be taken every evening and would be approved for use in premenopausal women with what’s known as hypoactive sexual desire disorder. It’s a condition said to affect 7% of premenopausal women that results in an unusually low sex drive that’s not being caused by any disease or other condition, according to Sprout Pharmaceuticals, which owns the drug.
It’s unclear exactly how big the market would be for the drug. But, if Viagra is any benchmark, it could be a cash cow. Viagra brought in annual sales of more than $2 billion for Pfizer at the drug’s height.
The FDA has already rejected flibanserin twice to date, arguing that its side effects don’t outweigh the risks. Some women’s groups claimed gender bias give that the governmental agency has approved drugs like Viagra for men but left half the population without an option.
However, the FDA countered in its previous reviews that the benefits were “numerically small but statistically significant” and not enough to counter the resulting low blood pressure, fainting, sleepiness, nausea and dizziness.