The Food and Drug Administration committee is mulling over plans to endorse the first pill designed to do for women what Viagra does for men.
A German pharmaceutical giant wants to sell a drug with the decidedly unsexy name "flibanserin," which has shown prowess for sparking a woman's sexual desire by fiddling with her brain chemicals.
The FDA's Reproductive Health Drugs Advisory Committee will meet on June 18 to consider the request.
But the prospect of the drug's approval has already triggered debate over whether the medication, like others in the pipeline, represents a long-sought step toward equity for women's health or the latest example of the pharmaceutical industry fabricating a questionable disorder to sell unnecessary and potentially dangerous drugs.
"Achieving a happy and healthy sex life can be a real and important problem for some women. But we have lots of questions about the 'pink Viagra,'" the Washington Post quoted Amy Allina of the National Women's Health Network, a Washington-based advocacy group, as saying.
Viagra's catapult to blockbuster status after its 1998 approval set off a flurry of interest in me-too medications for women.
However, drugmaker Pfizer's hopes that its "little blue pill" would also ignite female libido fizzled, making it clear that a woman's sexuality is more complicated than a man's.
But, Germany's Boehringer Ingelheim is optimistic that flibanserin is on the verge of becoming the first prescription medication to tap what some have estimated could be a 2 billion dollar market in the United States alone.
"We believe women deserve options and we're hoping flibanserin may represent a safe and effective option for many women," said Michael Sand, who heads the company's clinical research on flibanserin.
Scientists found that flibanserin, developed as an antidepressant, was ineffective for treatment of depression.
But the drug appeared to produce an unexpected side effect: boosting women's libido.
This prompted the company to study it for hypoactive sexual desire disorder, or HSDD, an otherwise unexplained loss of sexual thoughts, fantasies and desire that can cause significant emotional distress.
Some research suggests 10 percent of women may suffer from HSDD.
"It's not that they are averse to sex. It's just that they don't care about it. They just stop thinking about it. It's like a switch has been flipped. It's a loss for them. They miss it. And they want it back," said Anita H. Clayton, a professor of psychiatry and neurobehavioral sciences at the University of Virginia who has studied the drug for the company.
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