(CBS) — It’s been in the works for years: a pill to help women with low sex drives. Women who’ve tested it love it. So, why hasn’t it been approved? CBS 2’s Erin Kennedy explores the controversy.
Amanda Parrish, a busy working mother of four, says sex was often the last thing on her mind.
“It got to where I’d be one of those women who would try to maybe be asleep before he got to bed,” Parrish said.
Her doctor diagnosed HSDD or hypoactive sexual desire disorder.
The prescription: enter a clinical trial of flibanserin, a little pink pill designed to boost a woman’s low libido.
Amanda got results.
“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,” she said.
“It actually balances out dopamine and serotonin so that women have more sexual thoughts, more fantasies,” said Northwestern Medicine’s Dr. Lauren Streicher, describing how it works in the brain.
So, if flibanserin worked for Amanda and 45 percent of women in the studies, why has it been rejected twice by the FDA?
Experts noted it didn’t work much better than a placebo and others say therapy, not a drug, should be the first choice for busy, stressed-out women.
Outspoken critics, like Dr. Adriane Fugh-Berman, director of Georgetown University’s research project PharmedOut, are also concerned about side effects.
“15 percent of the women in flibanserin trials dropped out because of side effects of sedation and nausea and fatigue,” Dr. Fugh-Berman.
In 2013, the FDA requested new research on drug interactions and driving ability.
Dr. Fugh-Berman worries about the impact on women because flibanserin has to be taken every day, not just when women want to get in the mood.
“We don’t know what the long-term effects are of flibanserin because it hasn’t been tested long-term,” Dr. Fugh-Berman said.
Should women have access to a pill that would increase their libido?
“If this were a pill that were effective and didn’t have side effects… that might be a useful adjunct for women,” said Dr. Fugh-Berman.
Dr. Streicher says every drug has risks and isn’t right for everyone.
“Like any other new medication, the physicians need to be aware of who this drug will benefit, who it won’t benefit,” she said.
“It’s my hope that the FDA approves it. I’ll be the first in line to get it,” said Amanda Parrish.
Earlier this year, Sprout Pharmaceuticals, which makes flibanserin, submitted new research on the pill’s impact on driving ability to the FDA. Those results showed no adverse effect.
The FDA holds another hearing concerning the pink pill’s approval next month.