© Ian Hooton/Science Photo Library/Corbis
This Friday, the U.S. Food and Drug Administration will hear from an expert panel about the merits of, flibanserin, a drug that has been touted as potentially being the female equivalent of Viagra. Yet, an initial FDA review posted online today already indicates that Boehringer Ingelheim Pharmaceuticals, the manufacturer of flibanserin, may have trouble getting agency approval. According to Reuters, the FDA review of two flibanserin studies found the drug’s impact to be only “moderate,” and noted that it fell short on what was considered its primary function — increasing women’s overall sexual desire.
The studies did note that, while women’s overall sex drive was not enhanced by the drug, users did report having more satisfying sexual experiences. Unfortunately for Boehringer — and the many Wall Street investors hoping this little pink pill might enjoy the success of the little blue one — that wasn’t the primary measure of the studies. As the Associated Press reports, the FDA review stated:
“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.”
Not only did flibanserin — whose proposed trade name is Girosa — fall down when it came to lifting women’s libido, but, according to the FDA review, many women reported experiencing side effects such as dizziness, fainting and depression.
Should flibanserin fail to gain FDA approval, it will mark yet another dead end in the more than decade-long search for a female equivalent to Pfizer’s blockbuster Viagra. (As the AP points out, since Viagra’s debut in 1998, “more than two dozen experimental therapies have been studied for so-called ‘female sexual dysfunction,’ a market which some analysts estimate at $2 billion.”) And, as the search continues, the same question will persist: are the causes behind women’s waning sexual desire too complex to counteract by popping a pill?
As Catherine Elton wrote for TIME last year:
“Viagra works simply by increasing blood flow to the penis and producing an erection. In women, the issue is not about wanting to have sex and being physically unable; rather, it’s often that women lose interest in sex altogether, especially with the partner who once excited them. Beyond the many and varied psychological roots of the problem, there is still much that is not known about the biological processes governing women’s sexual desire.”
This week, in response to the FDA’s preliminary review of flibanserin studies, Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, echoed that idea. As she told the AP:
“It’s a fairly complicated area, unlike in men’s sexual dysfunction where there’s a major mechanical concern… In women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?”
That, for frustrated women and pharmaceutical companies alike, is the question.