Batterway: No green light for libido-boosting drug: US FDA

No green light for libido-boosting drug: US FDA

By Manager Online

21 June 2010 11:29

This photo retrieved June 18, 2010 is from http://media.photobucket.com. Women aged 30-60 mostly face the sexual desire problem whereas men's most common problem is the erectile dysfunction.

June 21, 2010
WASHINGTON (AFP) – A pink pill marketed by German drug firm Boehringer Ingelheimas a libido-booster for women has produced inconclusive results in two clinical trials, the US Food and Drug Administration (FDA) said.

Originally intended as an anti-depressant, the drug flibanserin -- in the form of a pink pill -- began being tested years ago as a potential libido aid after women said it failed to fight the blues but did boost their sex drive.

Lack of desire is the most common sexual problem in women aged 30 to 60, just as erectile dysfunction is the most common sexual disorder among men in the same age bracket, researchers said.

Clinical trials to test flibanserin's efficacy in raising the level of sexual desire in women were held in Canada, Europe and the United States.

The results of two US trials with the drug and a placebo were published on the FDA's website: "both failed to demonstrate a statistically significant improvement on the co-primary endpoint of sexual desire," said the FDA.

File photo shows people hugging during a "Cuddle Party" in New York City. Lack of desire is the most common sexual problem in women aged 30 to 60, just as erectile dysfunction is the most common sexual disorder among men in the same age bracket, researchers said. (AFP/Getty Images/File/Spencer Platt)

"Therefore, 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 administration added.

Besides the inconclusive results, the FDA noted the drug in some patients caused side effects including depression and dizzyness.

The FDA said its is waiting for recommendations on the little pink pill from an independent panel of experts due to report on Friday. The administration is not legally bound to comply with the advice, but usually does.

Boehringer Ingelhein has been researching flibanserin as a treatment for post-menopausal HSDD in women since the popular Viagra hit the market for male ED in 1998.

The potential market for a libido booster for women has been estimated by some analysts at around two billion dollars.

Medical research has found that 40 percent of women suffer from different degrees of HSDD.

Flibanserin belongs to a family of anti-depressants that acts on the body's level of serotonin, a molecule that plays a role in mood changes.

Batterway

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No green light for libido-boosting drug: US FDA

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