Female Viagra Drug Gets FDA Support

Female Viagra Drug Gets FDA Support
Flibanserin

The drug industry’s decade-old search for a female equivalent to Viagra took a major step forward Thursday after US government experts recommended the approval of a pill to boost sexual desire in women.

The first-of-a-kind endorsement came with safety reservations, however, due to drug side effects including fatigue, low blood pressure and fainting.

The panel of Food and Drug Administration (FDA) advisers voted 18-6 in favour of Sprout Pharmaceutical’s daily pill, Flibanserin, on the condition that the company develops a plan to manage its risks.

The recommendation is a major victory for a drug sometimes hailed as “female Viagra,” but which has been plagued for years by concerns of lacklustre effectiveness and safety issues.

The FDA has rejected the drug twice since 2010.

A similar panel of FDA experts voted unanimously against the drug five years ago.

Thursday’s vote is non-binding but the FDA often follows the advice of its experts. An official decision is expected in August.

FDA’s experts acknowledged that flibanserin’s effect is not very strong, but said there is a need for FDA-approved drugs to address female sexual problems.

“These are very modest results,” said Dr. Julia Heiman of the Kinsey Institute at Indiana University.

“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.”

Catherine Campbell, a wife and mother of two young boys, pushed on June 3rd  for US Food and Drug Administration (FDA) approval of flibanserin, an experimental women’s libido drug, despite concerns that it increased the risk of fainting and accidental injury, especially when combined with alcohol.

“To tell me that I can’t try a drug that could drastically improve my marriage, improve my life, because of dizziness and nausea is, to me, a cop out. We’re again dismissing it and we need to pay more attention and we need to take this seriously for once,” Campbell said during an interview in Washington.

ZERO SEXUAL DESIRE

Campbell, 30, said her sexual desire plummeted after the birth of her first child, who is now three.

“I had zero sexual desire. I don’t even say ‘low libido’, I say ‘no libido’. I went from being an incredibly flirtatious, sexually confident woman, being spontaneous, you know, usually the aggressive one and the one to initiate to not even thinking about it,” she said.

Campbell and her husband Chris traveled to the nation’s capital from their home in Indiana for an FDA meeting at which she testified on Thursday (June 4).

The FDA has once again raised concerns about the safety of flibanserin, citing concerns in a review published on Tuesday, two days before external advisers will recommend whether flibanserin should be approved.

Campbell said she does not want to see the lack of women’s libido drugs as sexist, but sometimes it is hard not to.

“I think it’s pretty pointless to help the men with their problems if we’re not going to do the same for the women.”

“I think it’s great that men are getting help. If men need, if men have a sexual dysfunction and they desire to have treatment to help themselves, then let’s get them the treatment.”

“I just want to be able to have the same options for myself. That’s all I’m asking,” she said.

Flibanserin is a selective serotonin reuptake inhibitor, or SSRI, similar to a class of antidepressants that include Prozac. It was originally developed as an antidepressant but was not effective

 

 

 

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Female Viagra Drug Gets FDA Support
Maureen Murimi
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