FDA Says No to "Female Viagra" Flibanserin

Flibanserin? Fuhgeddaboudit. The eagerly anticipated "female Viagra" has been rejected by the FDA panel responsible for evaluating new drugs before they can be marketed.

The panel said flibanserin failed to pass muster in two recent studies. In addition to causing significant side effects - including dizziness and depression - the drug didn't significantly increase women's sexual desire.

Women taking the drug reported slightly more sexually satisfying experiences, but the FDA said that was not the primary measure of the study.

"The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not," said the FDA review.

Pharmaceutical approaches to boosting female libido have evolved over time.

Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest.

In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble's testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.

The FDA has approved an unusual handheld vacuum device that increases blood flow to the clitoris to increase sexual arousal. But all drug therapies have fallen short so far.

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says that in most cases, a lack of sex drive has more to do with the quality of one's relationship and lifestyle than brain chemicals.

"It's a fairly complicated area, unlike in men's sexual dysfunction where there's a major mechanical concern," said Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York. "In women there's no mechanical concern, so if she's not having a successful sex life, where is the problem?"

But Boehringer Ingelheim, who makes flibanserin vehemently rejects the idea that women's sexual problems are all in their heads.

Hypoactive sexual desire disorder (HSDD) "is a medical condition - not simply 'low libido,'" they argued in a statement that argued that women taking their drug "showed improved measures of sexual desire, overall sexual functioning, and distress associated with low sexual desire."

Clearly, it wasn't enough for the FDA to desire flibanserin.