Sex Help for Older Women
Sale of testosterone-based gel at least two years away
By: Judy Peres
A small Chicago-area company is hoping to do what a pharmaceutical giant couldn’t: win FDA approval of a medication to boost flagging sexual desire in older women.
The drug–a form of testosterone called LibiGel that’s rubbed into the upper arm–is at least two years away from pharmacy shelves. But Lincolnshire-based BioSante Pharmaceuticals helped sponsor a meeting of sex experts last week, seeking to convince them the company’s on the right track.
Some are betting that a pill similar to an antidepressant could get there first. Boehringer Ingelheim Pharmaceuticals presented data at the same meeting showing that its drug, flibanserin, was significantly better than a sugar pill at improving the sex lives of women distressed over a loss of libido.
Lack of desire is typically women’s most common sexual complaint, and drug companies have been racing to offer a medical solution. The issue was a central topic at the meeting of the International Society for the Study of Women’s Sexual Health, which ended Sunday.
The discussion comes even as critics say a better answer for dissatisfied women often lies in less stress and more understanding partners. Critics also fear a drug purporting to treat female “dysfunction” could be misused and could convince women who aren’t unhappy with a low sex drive that they have a disease that needs fixing.
The quest for an approved drug was set back in 2004, when the U.S. Food and Drug Administration rejected the Intrinsa testosterone patch.
Procter & Gamble gave evidence the patch had succeeded in boosting desire, reducing sexual distress and increasing the number of “sexually satisfying events” (a deliberately vague term), with no serious side effects. But the FDA withheld approval, citing long- term safety concerns.
The patch has since been approved in Europe, and American women can buy it from online pharmacies. But U.S. doctors say most of their patients simply choose to use lower doses of testosterone products approved for men.
According to Stephen Simes, president and chief executive officer of BioSante, 1.4 million testosterone prescriptions a year are written for women, not counting medications prepared by compounding pharmacists.
Numerous studies have shown that testosterone, a steroid hormone produced naturally in men and women, is associated with sexual drive. Testosterone supplements are approved for men with abnormally low levels.
Women also lose testosterone after menopause, when the ovaries shut down, and many post-menopausal women complain about loss of sex drive, especially after surgical removal of the ovaries.
Sheryl Kingsberg, chief of behavioral medicine at Case Medical Center in Cleveland, said there are now four years of safety data on the testosterone patch with no evidence it causes serious health problems.
“Testosterone won’t help if you’re married to a schmuck,” she said.
Partly because it’s not a hormone, flibanserin is emerging as a favorite option among some experts.
Dr. Irwin Goldstein, director of sexual medicine at San Diego’s Alvarado Hospital, called the flibanserin presentation at the meeting “a historic moment” in the emerging field of female sexual dysfunction, analogous to the first time scientists saw evidence that Viagra could improve men’s erections.
How flibanserin increases desire is unclear. Michael Sand of Boehringer Ingelheim said the drug acts on serotonin receptors in the brain but does not appear to alleviate depression, as do other agents that affect serotonin.
BioSante hopes to overcome the FDA’s reluctance to approve a new hormone drug for women by mounting an innovative safety trial alongside conventional studies designed to show effectiveness.
In the safety study, they plan to recruit up to 3,000 women over 50 who have high blood pressure or some other risk factor for heart disease to see whether the testosterone gel causes heart problems. They also will follow those women for an additional four years to see if they develop breast cancer.
Tell us: Would you be interested in a “female Viagra”?