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FDA
Vote Against Female
Sex Drug
In
a move that could chill excitement about experimental drugs to
treat female sexual dysfunction, federal advisers refused to endorse
a new testosterone patch for women. Procter & Gamble sought to
market the Intrinsa patch to women with impaired libido due to
surgical removal of their ovaries.
The
company told a Food and Drug Administration advisory panel that
the drug had not raised significant safety concerns in clinical
trials. However, the advisory committee was unanimous that more
research was needed.
Clinical
trials showed that women who applied the patch to their abdomen
twice weekly had one more ``satisfying sexual event'' per four
weeks than did women given a placebo, according to the data presented
to the advisory panel.
Unlike Viagra, which enhances men's physical ability to have sex,
Intrinsa boosts women's desire for it. Removal of ovaries can
cause women's testosterone levels to drop by 50 percent. Although
men make more testosterone, women need some to have normal sex
lives, experts say. Fifteen of every 100 women who used Intrinsa
experienced a beneficial effect due to testosterone, Dan Shemas,
director of the FDA's division of reproductive and urologic drugs,
told the panel. By a 14-3 vote, federal advisers said that benefit,
compared with a placebo, was ``clinically meaningful.''
There
are known health risks when it comes to hormone therapy so it
may be worth more study and time to make sure that a drug like
this helps not harms women.
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