US health panel greenlights 'female viagra'
June 5, 2015
A United States health panel on Thursday recommended regulators approve a drug - deemed the "female viagra" - designed to boost female libido.
If the drug, called flibanserin, gets the green light from the US Food and Drug Administration (FDA), it would be the first approved pill of its kind targeting low female sex drive.
The panel of Food and Drug administration advisers voted 18-6 in favor of allowing the drug on the market, though with certain safety reservations to ensure that women are made aware of potential risks, and that doctors prescribe it only to women in need.
It is common for the FDA to follow the panel's recommendations.
Researchers say side the effects associated with filbanserin include nausea, dizziness and drowsiness. Experts at the panel hearing also raised the possibility of the pill being used as a "date-rape drug" in weighing potential benefits and risks.
But dozens of women told the panel about the problems caused by their low sex drive, and urged the FDA to approve the pill.
Women who had taken the drug during a recent test period spoke of its benefits.
"I am one of the lucky 11,000 women that was a patient on the flibanserin clinical trial," said Amanda Parrish, who said her low sex drive was causing marital problems. "What a relationship-saving eight months that was. As if the light switch had been turned on, so was I."
Despite the positive reviews, FDA experts say the effect of filbanserin is not very strong.
"These are very modest results," said Dr. Julia Heiman of the Kinsey Institute at Indiana University. "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."
The approval of the drug would represent marked progress treating low female libido. Five years ago, Germany's second-biggest pharmaceutical firm Boehringer Ingelheim halted the development of flibanserin, after the FDA at the time found little evidence that it worked.
The FDA is expected to render its decision on filbanserin, whose proposed trade name is Addyi, in August.
bw/bk (AP, AFP, Reuters)