Procter & Gamble - the equivalent of a blinking red light.
Thus the FDA wants extensive five-year clinical trials involving thousands of women.
Even two recent studies that indicated that Intrinsa significantly helped women and led to an increase in "satisfying sexual events" is unlikely to change the mind of the FDA as it is set for a review of the drug, according to the report.
One study published last week in the Archives of Internal Medicine found that women who used the patch for 24 weeks reported, on average, a 67 percent increase in their sexual desire, compared with a 48 percent increase in desire reported by women taking a placebo, or dummy pill.
It also boosted the number of "satisfying sexual encounters" from an average of three per month to about five.
A similar finding was reported in May by researchers at Baylor Medical College.
The issue has sparked a debate in the medical world, with some experts applauding the FDA for its cautious approach and others charging it with setting a higher standard of safety for drugs designed to increase female sexuality.
Procter & Gamble remained confident that the hurdles could be overcome.
"We're in talks with the FDA, working out a practical approach to address their concerns about safety," said spokeswoman Elaine Plummer, adding that no studies to date have suggested serious negative effects.
Medindia on Viagra:
ViagraTM is the first approved non-surgical treatment for erectile dysfunction that does not have to be either injected or inserted directly into the penis to achieve and maintain erection. The US Food and Drug Administration (FDA) approved it for prescription sale at the end of March 1998. Viagra does not directly cause penile erection, but affects the response to sexual stimulation.
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