Sexual desire…there’s a drug for that!
It’s been dubbed “female Viagra” or “the little pink pill,” and it’s been in the center of a heated debate over gender equality in medicine.
Flibanserin, developed by Sprout Pharmaceuticals, is once again being reviewed but the FDA. The agency rejected the drug during two prior reviews. The drug was developed to treat women who have been diagnosed with hypoactive sexual desire disorder (HSDD), meaning, they have no desire to have sex.
“I am very hopeful that the third time will finally be the charm, and I think millions of women are also hopeful,” said Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center in Cleveland, Ohio. Kingsberg is also a paid consultant for Sprout Pharmaceuticals.
Flibanserin is meant to address the biological causes of HSDD, to correct malfunctioning neurotransmitters in the brain. “Just like with somebody suffering from depression, there are changes in brain chemistry that affect their interest, their wanting to have sexual activity,” said Kingsberg.
Kingsberg said that hypoactive sexual desire disorder affects about seven to ten percent of U.S. women, and stressed that it’s different from a natural decline in desire that might come with age. She explained that hypoactive sexual desire disorder means that a woman’s relationship is otherwise good and healthy, that she’s had a satisfying sex life in the past, but her desire has vanished completely, causing suffering.
“We have data that women that suffer from this disorder experience a profound negative impact on quality of life, on body image, relationships,” said Kingsberg. “When sex is good in a relationship, it adds some value, maybe 15 to 20 percent added value. But when sex is bad or nonsexist, the impact is far more profound. Bad sex does way more to subvert an otherwise good relationship than good sex does to save a bad relationship.”
Kingsberg likes the term “female Viagra” even though she admits that flibanserin is a completely different drug than Viagra, which addresses blood flow issues. “I like that it’s been called the ‘pink Viagra,’ it reflects similar concepts in that it is the first drug to treat female sexual disfunction.”
Kingsberg is also one of the spokespeople for “Even The Score,” the lobbying campaign backing flibanserin.
“There are drugs that are approved by the FDA to treat some form of male sexual disfunction, like erectile problems, and there are zero approved drugs for any form of sexual disfunction in women, except the vaginal atrophy that is the result of menopause,” said Kingsberg.
Turning the drug’s approval into a gender equality issue has certainly put public pressure on the FDA, but Kingsberg maintains it’s in the best interest of patients.
“I have been treating these women for the last 25 years, and there has been no pharmacological option for them, and I have watched them suffer. A whole group of women, they have a biologic cause for their loss of desire, and I have no options for them.”
But Kingsberg doesn’t think that the equality issue has been played up in order to force an FDA approval.
“When we look at the risk benefit analysis, for men, when you look at the drugs and the side effects, hearing loss, penile rupture as potential risks, and when we look at the most common adverse effects of flibanserin, it’s sleepiness, dizzy, nausea and headaches.”
The FDA may rule on the drug in the next few months.