‘Little pink pill’ gets FDA approval

First libido drug for women — just don’t call it ‘Viagra’

A “little pink pill” designed to boost women’s libido won approval from the Food and Drug Administration on Tuesday, becoming the first such drug on the market alongside medications to improve sexual function in men.

“It’s been a long time coming,” says Cindy Whitehead, CEO of drugmaker Sprout Pharmaceuticals of Raleigh, N.C. “This opens the door to medical treatment for women” never available before.

Flibanserin, which Whitehead says should hit the market by Oct. 17 under the brand name Addyi, has been dubbed “Viagra for women” even though it works very differently from the erectile dysfunction drug for men. Viagra is taken before sex and increases blood flow to the genitals. Flibanserin is taken daily before bedtime and affects brain chemicals.

The FDA has rejected the drug twice in the past five years, but an advisory panel of medical experts in June voted 18-6 to recommend approval if more safety restrictions were added. Panelists expressed concerns about potential side effects such as low blood pressure, fatigue and fainting, and questioned data on how the drug may interact with alcohol or birth control pills.

But supporters say the benefits may outweigh the risks for many. Rep. Jackie Speer, D-Calif., and 10 other Congress members signed a letter to the FDA saying: “We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a women.”

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The drug has gotten a big marketing push from an advocacy group called Even the Score, which is supported by Sprout.

Kenneth Payne, with Norton OB/GYN Associates in Louisville, says he would consider prescribing the drug to patients for whom the benefits outweigh the risks. “The jury’s still a little bit out on this,” he says.