SILVER SPRING, Md. – Under intense pressure, the Food and Drug Administration opened its doors this week to hear directly from patients, providers and advocates on what many call an unmet medical need for women: sexual dysfunction.
There are currently 24 FDA approved drugs on the market for male sexual dysfunction but zero for women.
Hundreds from across the country urged the agency to even the score. One by one, women bared their souls, on this very personal subject.
“My sexual experiences recently are more out of obligation to keep my husband satisfied. After all, this is not his fault this is happening to me. I found myself avoiding any situations where a sexual experience may occur. For example, going to bed after my husband fell asleep or jumping out of bed in the morning before he got up, just so he wouldn’t try to initiate sex,” one woman told a panel of female FDA officials during a hearing Tuesday at the agency’s headquarters in Silver Spring.
Those who testified called on the FDA to act urgently to address the lack of treatment options for women who suffer from the most common form of female sexual dysfunction, Hypoactive Sexual Desire Disorder, which afflicts millions of American women. Nearly half of all women will suffer low sex drive at some point in their lives.
Many of the women who testified expressed anger and frustration that their husbands could go to their doctor and be prescribed any number of FDA-approved medications covered by insurance but they have no options.
Clinical trials involving thousands of women have found some success in searching for the female equivalent of Viagra. But to date, the FDA has not given any drug approval.
Dr. James Simon, the professor of obstetrics and gynecology who led a clinical trial for the drug Flibanserin at George Washington University, says the drug has been through 12 years of vigorous trials to review safety, side effects and effectiveness.
“Flibanserin’s been studied in about 11,000 women now. That’s about ten fold more than any single trial of any of those 24 medications for men,” Simon said.
The drug works by boosting desire by raising neurotransmitters in the brain. The drug would be specifically approved for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
The FDA is concerned that Flibanserin’s side effects, which include dizziness, nausea, and fatigue, outweigh its modest benefits. He sees this willingness on the part of the FDA to hear from patients and advocates as very promising.
“I think to myself, I’m only 29 years old. Am I just going to be like this forever? Is there no hope for me to get back the feelings I had before? Women like me who feel this way need a solution. We deserve to feel our sexual desire again,” said the woman, who was the first to testify during the two-day hearing.
Because so many factors affect female sexual appetite, there are a number of other possible causes doctors must rule out before diagnosing the condition, including relationship problems, hormone disorders, depression and mood issues caused by other drugs like sleeping aids and pain medications, the Associated Press has previously reported.