FDA Rejects Libido Pill For Women Despite Promising Results
BOSTON (CBS) - "You can't turn on the TV at night without seeing commercial after commercial after commercial for Viagra or Cialis or testosterone for men," says Amanda Parrish. "We deserve to have fun too. Why is that men get to have fun in the bedroom and women are not supposed to?" Parrish is not shy when it comes to talking about her sex life or even the lack of it. "It got to where I'd be one of those women who would try to maybe be asleep before he got to bed."
So, this busy working mother of four went to her doctor and received a diagnosis of HSDD or Hypoactive Sexual Desire Disorder. Parrish was quickly enrolled in a clinical trial for Flibanserin, a daily pill that promises to do for women what Viagra did for men. The so-called little pink pill delivered results for Parrish and her husband. "It was not like I became randy 24/7. It's just simply at the end of a long day, even if I had worked, and even if I had gotten the kids fed, there was a desire there that previously had not been there."
Problem solved, right? Wrong. Flibanserin has now twice been rejected by the FDA. In a study the drug maker found 45% of women reported a meaningful benefit, or increased desire, while taking the drug. That was slightly more than the 35% taking a placebo. The FDA concluded that benefit did not outweigh the side effects, like sleepiness, dizziness, and nausea. The drug maker, Sprout, is now asking the FDA to reconsider. "It's not just that there's practically nothing for women... there's nothing FDA approved for women when it comes to HSDD," says Parrish.
"It's not fair that there is a double standard but I don't think it's completely unreasonable that we have a high bar for safety when we are looking at drugs for low libido for men or women," says Dr. Jan Shifren of Massachusetts General Hospital. Dr. Shifren treats women with female sexual dysfunction and she believes couples should work on their relationship first but drug therapy is needed for some women. "Probably 90% of libido is from the neck up." And that's how Flibanserin works. It increases the sex drive by altering chemicals in the brain.
"It was just a light switch in my head that been turned off. And once it got turned on things were fine," explains Parrish. Now in the dark, without the pill, she is pushing for the drug's approval. "It's my hope that the FDA approves it. I'll be the first in line to get it."
An answer for Parrish, and thousands of women like her, is expected from the FDA this summer.