Federal health experts found unanimously today that the first so-called “female viagra” sex pill did not show strong enough results to warrant approval.
Boehringer Ingelheim GmbH’s sex-drive drug flibanserin doesn’t provide enough benefits to outweigh its risks, according to a U.S. panel reviewing the first pill designed to boost women’s libidos.
As we reported on this blog last November, Boehringer Ingelheim's pink pill flibanserin was the latest drug industry offering to target women with low sex drive, a market potentially worth billions.
But members of the Food and Drug Administration's reproductive drugs panel meeting in Gaithersburg, Maryland voted today 11-0 that the drug's benefits did not outweigh side effects, including fatigue, depression and fainting spells. The advisory panel is comprised of a group of experts from outside the FDA.
Earlier, the same panel voted 10-1 that the drug isn’t effective. In fact, Flibanserin failed to increase sexual desire, as recorded by women in daily journals, in two company studies.
While the FDA usually follows its advisory panels’ recommendations, it isn’t required to do so. The FDA is expected to make its own decision on the drug in several months. The drug's proposed brand name is Girosa. It is not yet approved anywhere in the world.
Earlier this week, the FDA released a review of two studies that found the drug didn't have much impact on a woman's libido but did seem to slightly boost sexual satisfaction, according to published reports.
The drug's tolerability was "only moderate," FDA staff said. Nearly 15 percent of women who took the recommended flibanserin dose stopped doing so before the study ended due to possible side effects. Depression, fainting and fatigue were among the problems reported by women who took the drug.
Boehringer Ingelheim, in a document also posted to FDA's website Wednesday, explained that flibanserin is aimed at treating women who previously had a level of sexual desire that was satisfactory to them and lost that desire "in all situations and across significant levels of time." The company said women typically need to be distressed or upset by their loss of sexual desire."
Hypoactive Sexual-Desire Disorder (HSDD) is not simply due to stress or the result of fatigue, or of being a working mother with small children," the company said.
The company said women with HSDD currently have "extremely limited" treatment options and that flibanserin provides such an option. Boeringer Ingelheim said treatment with flibanserin resulted in women having "clinically relevant" improvements in sexual desire, sexual activity and sexual function.
Several medical trials, including a study published in the New England Journal of Medicine, say that at least 40 percent of women suffer from varying degrees of sexual hypoactivity, though critics warn that drug companies have funded a number of these surveys.
An analysis of the two clinical trials published on the FDA's website note 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 who took a placebo.
"Neither study met the agreed-upon criteria for success in establishing the efficacy of flibanserin for the treatment of HSDD," the FDA added.
The two-year studies, measured by women's diary entries in the United States and Canada, 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 – most of them married with a high education and good health apart from their decreased libido – had reported an average 2.8 satisfying experiences before taking the medicine.
Flibanserin belongs to a family of antidepressants that reduce the level of serotonin, which has an effect on mood and can put a damper on sexual desire.
The drug also controls the levels of dopamine and norepinephrine in the blood, substances that act on sexual desire, the pill's manufacturer said.
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.
According to Tiefer, one of the experts presenting their advice before the FDA, 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.
But 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."
The drug was discovered by accident — after it failed trials as an antidepressant. Originally, flibanserin was developed as an anti-depressant, but turned out to be a poor one. Questionnaires given to patients helped discover the drug possessed libido-boosting side effects, and many of the women who participated in the trial seemed reluctant to give back the drug.
One of the most interesting aspects of the drug is that it underscores the fundamental difference between the way sexual arousal works in men and women. The drug hoped to be marketed to women works on their brains, while male impotency pills such as Viagra, Eli Lilly's Cialis and Bayer's Levitra, widen blood vessels to increase the blood flow to the penis needed for an erection. These same male impotence pills, have failed to show notable aphrodisiac effects in women.
Paula Hall, of Relate, urges caution. "Female loss of libido is a big problem and it is not going away. It can cause problems within a relationship and affect self-esteem. This research is really quite exciting for women with loving partners whose loss of libido is a physical thing. But it is not going to fix a broken relationship or help with looking after the kids or cleaning the house," Hall said.
For some women AND men, reduced sexual interest or response may be "normal," doctors say.
Men’s Viagra was originally meant to be a treatment for high blood pressure, and the heart condition angina. As with the women in this study, men taking part in early trials of the drug realized it had an interesting and unexpected side effect: Erections! Arriving in 1998, the drug has since been prescribed for over 25-million men.
From the beginning, the new drug has proven controversial among sex researchers, with some arguing the pharmaceutical companies are exaggerating the number of women affected by low libidos, simply as a market expansion ploy by pushing a pill unable to deal with psychological issues responsible for putting someone off sex, e.g. poor body image, former abuse, or stress.
I find it even more interesting that the firestorm ‘erupting’ over this drug has far exceeded anything related to male impotency drugs. In fact, discussions focusing on the meaning of sexual desire were sadly, and noticeably missing when Viagra-type medications were on the horizon. It was the primarily the physical impact of those medications on patients that were discussed, not their psychological effects on users.
In 2003, a year after Boehringer researchers began the clinical trials, an article written by Ray Moynihan in the British Medical Journal called female sexual dysfunction, “the freshest, clearest example we have” of a disease created by pharmaceutical companies to make healthy people think they need medicine.
“This is for some an ideological battle,” said psychiatrist Michael Berner of the Freiburg University Clinic, who had patients in Boehringer’s studies. “One view is the multi-dimensional view you get from people like me. And then you have these people that say you should work only on relationship issues and that medication cannot have a place.”
Flibanserin is believed to work on the brain by putting “two feet on the brakes” to block the release of a chemical called serotonin, which regulates mood, appetite, sleep and memory. In time, the process should trigger the production of dopamine, a chemical that, among other jobs, helps stimulate desire. The drug differs from testosterone, a hormone that’s also been tested to reawaken women’s desire.
After as an initial period of hesitation about developing a sex pill, Boehringer officials decided to move forward. The company needs new drugs because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection this year.
In my opinion, which I expressed last year, the company did a lot of pre-publicity for this drug, hoping that the worldwide conversation would impact the FDA panel’s decision, and to soften other markets – like in the U.K.
I can only hope that each and every country does its own studies, and acts in the best interest of women – not commerce.
— The Curator