FDA panel review looms for controversial libido drug

The first time researchers studied flibanserin, they thought they had a potential new depression therapy on their hands. That approach failed. But now Boehringer Ingelheim is preparing to make the case to a panel of FDA experts that the drug should be approved to boost women's libido, seeking an approval for a 'pink Viagra' that could earn up to $2 billion a year.

The agency's views have yet to be heard, but there's already plenty of debate in women's health circles about the prospects of a new drug to treat a condition that some find questionable. The clinical term for the condition is hypoactive sexual desire disorder, or HSDD, a loss of sexual desire which could affect up to 10 percent of all women.

Boehringer gathered data on more than 5,000 pre-menopausal women and determined that the group taking flibanserin achieved an average of 4.7 satisfying sexual experiences a month compared to 2.7 before they were treated and 3.7 in the placebo group. The company is likely to face some tough questions on the narrow difference of response seen between the drug group and the placebo group.  

"Achieving a happy and healthy sex life can be a real and important problem for some women," Amy Allina of the National Women's Health Network tells the Washington Post. "But we have lots of questions about the 'pink Viagra.'"

The agency's committee on reproductive health drugs meets June 18.

- here's the article from the Washington Post

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