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World's First Female Viagra: FDA Panel Backs Flibanserin With Safety Restriction

by Vishnuprasad on June 6, 2015 at 12:32 PM
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World's First Female Viagra: FDA Panel Backs Flibanserin With Safety Restriction

A US Food and Drug Administration (FDA) panel has recommended what could pave the way for the world's first drug to treat lack of sexual desire in women by mid-August.

The advisory committee has backed the approval of flibanserin, a drug that is counterpart to Viagra - the widely used drug for male erectile dysfunction, the New York Times reported.


The drug could potentially be approved by August 18 - the FDA deadline - this year. The US agency usually follows the advice of its advisory committees.

"The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point," Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey, was quoted as saying.

The pink pill, taken once a day at bedtime, would be approved for pre-menopausal women suffering a lack of sexual desire that causes them distress.

Nearly seven percent of pre-menopausal women have this condition called hypoactive sexual desire disorder.

The drug works by influencing the level of certain chemicals like serotonin and dopamine in the brain.

Women who took part in three clinical trials had an average of two to three of what they defined as "sexually satisfying events" per month.

Once they started taking the drug, the number of such events increased.

Women on flibanserin also reported feeling more desire.

However, the side effects like low blood pressure and fainting should be taken into account while prescribing the drug for women, the trial studies suggested.

The move has been hailed by some women's organisations as a step toward sexual equality.

"Today, we write a new chapter in the fight for equity in sexual health," Susan Scanlan, chairwoman of the Even the Score coalition, said in a statement.

Source: Medindia

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