2/18/2015
WASHINGTON – The American company Sprout Pharmaceuticals applied once again Tuesday to the U.S. Food and Drug Administration, or FDA, for approval of the drug flibanserin, developed to stimulate sexual desire in premenopausal women.
“Men have a number of treatment options for sexual dysfunction,” said Sprout CEO Cindy Whitehead in a communique. “We haven’t yet gotten to one for women’s most common dysfunction.”
The FDA had already twice rejected Sprout’s application for its approval of flibanserin as an antidote for Hypoactive Sexual Desire Disorder, or HSDD, arguing a lack of medical proof of its effectiveness and little guarantee of its safety.
For this latest application, the company offered the results of extensive new clinical trials to validate the effectiveness of a drug that some have already christened the “female Viagra.”
According to data from the most recent studies by the North Carolina-based pharmaceutical company, the medicine was able to increase sexual desire by 53 percent in the women examined, reduced their complaints by some 29 percent and doubled the number of satisfactory sexual experiences in the 11,000 women who took the test.
Joining the manufacturer in defending the drug, the first of its kind, were women’s rights groups, which said the FDA has imposed higher standards of safety on flibanserin than on similar drug products for men.
source
WASHINGTON – The American company Sprout Pharmaceuticals applied once again Tuesday to the U.S. Food and Drug Administration, or FDA, for approval of the drug flibanserin, developed to stimulate sexual desire in premenopausal women.“Men have a number of treatment options for sexual dysfunction,” said Sprout CEO Cindy Whitehead in a communique. “We haven’t yet gotten to one for women’s most common dysfunction.”
The FDA had already twice rejected Sprout’s application for its approval of flibanserin as an antidote for Hypoactive Sexual Desire Disorder, or HSDD, arguing a lack of medical proof of its effectiveness and little guarantee of its safety.
For this latest application, the company offered the results of extensive new clinical trials to validate the effectiveness of a drug that some have already christened the “female Viagra.”
According to data from the most recent studies by the North Carolina-based pharmaceutical company, the medicine was able to increase sexual desire by 53 percent in the women examined, reduced their complaints by some 29 percent and doubled the number of satisfactory sexual experiences in the 11,000 women who took the test.
Joining the manufacturer in defending the drug, the first of its kind, were women’s rights groups, which said the FDA has imposed higher standards of safety on flibanserin than on similar drug products for men.
source
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