6/08/2015

'Female Viagra' nears US approval after expert backing

A tablet of flibanserin sits on a brochure for Sprout PharmaceuticalsA US government panel has urged regulators to approve a drug to treat low sexual desire in women, nicknamed the "female Viagra".
The experts backed flibanserin, but said it must carry warnings about strong possible side effects including fainting and tiredness.
The final decision now moves to the US Food and Drug Administration (FDA).
The FDA has rejected the drug twice since 2010 but it usually follows the advice of its experts.
Women taking the drug reported between 0.5 and one more sexually satisfying event per month, results experts admitted were "modest".
"But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem," said Dr Julia Heiman of the Kinsey Institute at Indiana University.

'Life-changing'

One patient who received the drug explained its appeal.
"I want to want my husband, it is that simple,'' said Amanda Parrish. "For us, flibanserin is a relationship-saving and life-changing drug.''
Lobbying by the drug's developer, Sprout Pharmaceuticals, was aided by the women's rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating erectile dysfunction in men without passing an equivalent for women.
But some criticised the campaign as providing cover for a drug with marginal effects.
"To approve this drug will set the worst kind of precedent - that companies that spend enough money can force the FDA to approve useless or dangerous drugs," said, Dr Adriane Fugh-Berman of Georgetown University, the New York Times reported.
If approved, flibanserin will be aimed at pre-menopausal women. The panel suggested several risk management measures, such as requiring physicians to hold a certificate before prescribing the drug.

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