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Female Viagra Rejected By FDA

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Female Viagra Rejected By FDA

Drug makers sent back to lab in the quest for female Viagra…

The drug widely touted as the new female Viagra has been rejected by the FDA advisory panel, ruling that the new pill ‘showed little evidence of working and raised safety concerns.’

The drug, known as flibanserin, was originally designed as an antidepressant but further analysis stirred a belief that the drug may work to increase sexual desire in women. Unlike Viagra, which can be taken minutes before sex, flibanserin must be taken every day. And while Viagra works on the physiology of the penis, flibanserin acts on the central nervous system, presumably on the pleasure centers on the brain.

female viagra rejected by fda Female Viagra Rejected By FDA

Flibanserin Female Viagra Rejected By FDA

Bryce Reeve, PhD, program director of the Outcomes Research Branch at the National Cancer Institute and a member of the advisory committee said: This is not an effective drug,

Aside from the less than convincing results, the panel were also concerned that company abandoned the scale it used to measure the women’s experience after initial results were below expectations.

Scott Emerson, MD, a professor of biostatistics at the University of Washington and a member of the advisory panel. This would be highly inappropriate,

German pharmaceutical makers Boehringer Ingelheim, had hoped to market and sell flibanserin to treat hyposexual desire disorder, HSDD. However the FDA verdict will now send drug makers back to the drawing board if they are to create an effective treatment for the condition that plagues more than 6% of women aged between 30 and 39 years old.

The decision leaves the medical community divided. Anita Clayton, MD, a University of Virginia professor of psychiatry who testified on behalf of Boehringer Ingelheim, said:

Women suffering with HSDD deserve the option to choose a safe and effective pharmacotherapy for this distressing condition,

Clayton and many other experts believe that HSDD is a ‘potentially devastating condition adversely affecting millions of women.’ But others believe the condition is nothing more than a ploy pushed by drug companies in order to sell treatments noting that ‘there is no scientifically accepted definition of normal sexual desire, much less reduced desire.’

Flibanserin is not a choice when its promoted by bad science and half truths, said Leonore Tiefer, PhD, an associate professor of psychiatry from New York University who testified against the drug.

In addition to questionable results, experts also raised safety concerns regarding the one in seven women
who dropped out of two company studies due to adverse reactions including depression, dizziness, nausea, and fatigue.

Despite rejecting flibanserin, panelists did stress a belief that HSDD is a treatable clinical disorder in women.

I hope [Boehringer Ingelheim] and others do look for a way to help women out, Reeve said.


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