June 19, 2010
Female Sex Drive Pill Debated In US
On Friday, a U.S. panel of experts debated to approve the first pill that helps boost a woman's sex drive, as its German manufacturer pressed for the drug to reach the lucrative market.
Boehringer Ingelheim officials wanted to convince the U.S. 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 is the latest effort to come up with a female counterpart to the wildly popular male erectile dysfunction pill Viagra. It 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 $2 billion ever since Viagra's phenomenal success since its approval for in 1998.
A study published in the New England Journal of Medicine said that at least 40 percent of women suffer from varying degrees of sexual hypoactivity, though critics warn that big pharmaceutical company has funded a number of these surveys.
An analysis of the two clinical trials published on the FDA's website said 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 that took a placebo.
The FDA also said "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 two-year studies 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 had reported an average of 2.8 satisfying experiences before taking the medicine. Most of the women were married with a high education and good health apart from their decreased libido.
The FDA said flibanserin can also cause side effects like depression or dizziness.
Flibanserin belongs to a family of antidepressants that reduce the level of serotonin. This has an effect on mood and can damper sexual desire.
The pill's manufacturer said that the drug also controls the levels of dopamine and norepinephrine in the blood, substances that act on sexual desire.
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.
Tiefer said 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.
However, 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."
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