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Archive for Friday, December 3, 2004

FDA calls for more testing on female sexuality drug

December 3, 2004

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— The first drug to treat female sexual dysfunction isn't ready for the market yet because of safety concerns, a federal advisory committee cautioned Thursday.

"I think it's to everybody's good to wait a little bit," said Dr. Larry Lipshultz, a urologist and a member of the Food and Drug Administration's advisory committee for reproductive health drugs.

The committee voted unanimously Thursday against the use of Intrinsa as a sex drive-increasing drug for women made menopausal by surgery. The panel deemed inadequate an initial round of clinical trials by drug maker Procter & Gamble and unanimously recommended more safety tests.

"I don't want to expose several million American women to heart disease and stroke in order to have one more sexual experience a month," said committee consultant Dr. Steven Nissen, a cardiologist.

The decision isn't a disapproval of Intrinsa but a recommendation to the FDA to reject the drug when the agency makes its decision later this month.

Intrinsa, developed by Watson Pharmaceuticals Inc. and now licensed to Procter & Gamble, uses a skin patch to deliver testosterone, a hormone that menopausal women often lack. The hormone is produced in larger quantity in men and is responsible for male characteristics such as facial hair and a deeper voice. Women's bodies also produce testosterone, which is believed to contribute to libido, but in a smaller amount.

Hormonal drugs like Intrinsa also have sparked concern because of links to heart disease, stroke and breast cancer.

Intrinsa generated instant buzz as a "female Viagra" with vast market potential, but the tag is a misnomer. While Viagra treats erectile dysfunction in men, Intrinsa is aimed, at least in its pending FDA application, at young and middle-aged women who've undergone ovary removal surgery, which triggers "surgical menopause." The operation often results in a decreased interest in and satisfaction from sex.

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