Sex pill for women's future dim, for now
A US panel of experts debated Friday whether to approve the first pill that helps boost women's sex drive, as its German manufacturer pressed for the drug to reach the lucrative market.
Boehringer Ingelhein officials sought to convince a panel before the US Food and Drug Administration (FDA) that their little pink pill was harmless and effective.
The FDA usually follows these panels' advice, even though it is not required to do so by law.
Flibanserin, the latest effort to come up with a female counterpart to the wildly popular male erectile dysfunction pill Viagra, works on brain chemicals to treat premenoposaul women who have a low sex drive.
Pharmaceutical firms have vied for a spot in this potential market estimated to be worth two billion dollars ever since Viagra's phenomenal success ever since its approval for market in 1998, subsequently followed by competitors Cialis and Levitra.
Several medical trials, including a study published in the New England Journal of Medicine, say that at least 40 percent of women suffer from varying degrees of sexual hypoactivity, though critics warn that big pharma has funded a number of these surveys.
Hopes that the expert panel will recommend commercializing the once-a-day flibanserin appear dim.
An analysis of the two clinical trials published on the FDA's website note that both "failed to demonstrate a statistically significant improvement" in sexual desire, even though patients who took flibanserin had slightly more satisfying sexual relations with their partners than those who took a placebo.
"Neither study met the agreed-upon criteria for success in establishing the efficacy of flibanserin for the treatment of HSDD" (Hypoactive Sexual Desire Disorder), the FDA added.
The two-year studies, measured by women's diary entries in the United States and Canada, found that women who took flibanserin reported an average 4.5 more satisfying sexual experiences per month, versus 3.7 for those who took a placebo.
The women -- most of them married with a high education and good health apart from their decreased libido -- had reported an average 2.8 satisfying experiences before taking the medicine.
According to the FDA, flibanserin can also cause side effects such as depression or dizziness.
Flibanserin belongs to a family of antidepressants that reduce the level of serotonin, which has an effect on mood and can put a damper on sexual desire.
The drug also controls the levels of dopamine and norepinephrine in the blood, substances that act on sexual desire, the pill's manufacturer said.
Sexual therapist Leonore Tiefer of the New York University School of Medicine and Albert Einstein College of Medicine expressed worries that commercializing the pill would disappoint many women.
According to Tiefer, one of the experts presenting their advice before the FDA, the emotional complexity of female sexuality and the types of problems that may arise usually are not linked to medical problems.
"Is there a small group of women who could benefit from medical intervention? Probably," she told The New York Times.
But she cautioned that "the much larger group of women without any medical reason for their sexual distress will inevitably be misinformed and misled into thinking that there is a pill that can get them the sex life they read about, the one they think everyone else is having."
© 2010 AFP