WOMEN-LIBIDO/FDA U.S. woman pushes for FDA approval of female libido drug

Record ID: 149988

  • Title: WOMEN-LIBIDO/FDA U.S. woman pushes for FDA approval of female libido drug
  • Date: 3rd June 2015
  • Summary: WASHINGTON, D.C., UNITED STATES (JUNE 3, 2015) (REUTERS) VARIOUS OF KATHERINE AND CHRIS CAMPBELL SITTING ON A PARK BENCH (SOUNDBITE) (English) KATHERINE CAMPBELL, WHO WANTS THE FDA TO APPROVE FLIBANSERIN, SAYING: "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
  • Embargoed: 18th June 2015 13:00
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  • Topics: General
  • Reuters ID: LVABQIYNKHCRFVD4591QEYPA4T3S
  • Aspect Ratio: 16:9
  • Story Text: Katherine Campbell, a wife and mother of two young boys, pushed on Wednesday (June 3) for U.S. 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.
    Campbell, 30, said her sexual desire plummetted 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 will testify 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.
    The drug's developer, privately-held Sprout Pharmaceuticals, is seeking approval of flibanserin for premenopausal women whose lack of sexual desire causes distress. The proposed trade name of the product, if approved, is Addyi.
    The FDA review found a statistically significant improvement in the number of satisfying sexual events (SSEs) experienced by women taking the drug and a reduction in distress related to low desire. There was an increase in desire as measured on a monthly, though not a daily basis.
    The differences were numerically small, however, and the question remains whether the drug's benefits outweigh the risks, the FDA said.
    Campbell said after being mocked by some about her problem, she sought a medical solution, but was disappointed to find there was no drug to treat her disorder.
    "I asked him, I said what do you have for no libido? I have no sex drive anymore. And he said we have nothing for women with your type of sexual dysfunction, but we can just try stuff, and maybe it will work, and I though --- what? You know, my type of sexual dysfunction -- so obviously I'm not the only person who has this but then you tell me you have nothing to treat it," she said.
    The agency has twice rejected flibanserin, saying its modest efficacy was outweighed by side effects, which also include nausea, dizziness and sleepiness.
    The drug's arduous journey through the approval process has prompted accusations from some women's groups of a double standard and gender bias at the FDA. The agency has approved some two dozen drugs to treat male sexual dysfunction, and none for women.
    A video released by the Even The Score organization mocks the Viagra ads on television.
    "Men who take erectile dysfunction medication may find it entirely useless if their partner does not have any sexual desire," a deep-voiced narrator says at the end of the video, which features a woman lying on a bed in a beach cabana.
    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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