After weeks of anticipation and debate, an FDA advisory committee decided a Boehringer Ingelhim pill that was tested for treating Hypoactive Sexual Desire Disorder in women was neither safe nor effective. The voting was rather stark - all 11 panelists decided the side effects were unacceptable, and 10 ruled the pill, known as flibanserin, is not effective.
The outcome is hardly surprising, given concerns outlined by FDA reviewers in briefing documents that were released prior to the meeting. The pill did show a statistically difference in generating sexually satisfying experiences compared with a placebo (read the report) - women reported an average of 4.5 per month compared with 2.8 before taking the pill, while the rate jumped to 3.7 for those on placebo.
But there was no statistically significant improvement on the co-primary endpoint of sexual desire as measured by diary entries. And there had been some to-ing and fro-ing over the diaries - the FDA required daily entries by women in the studies, but Boehringer provided monthly reports.
Meanwhile, the drug was only moderately tolerable - nearly 15 percent stopped taking the pill due to possible side effects. The FDA reviewers also noted many medicines and medical conditions were excluded from the trial, suggesing it was not clear whether the safety and efficiacy data from the clinical trials could be extrapolated to the general population (read more). Hardly a selling point.
The run up to the meeting was characterized by a full-scale promotional push and heated debate over the validity of using medication to treat HSDD, which some refer to as Female Sexual Dysfunction. Some critics even question the extent to which HSDD has been legitimatized in the Diagnostic and Statistical Manual of Mental Disorders (more here). In any event, the FDA panel vote leaves US women without what some like to call a female equivalent to Viagra, at least for now.
10 Comments
I do wish you would stop perpetuating the fallacy that this is a "female Viagra"
Harpy, from what I've read about it, it seems more like this would be like a "prescription Ecstacy" than a Viagra for Women. Desirable effects for the drug profile would be like some of the mood and sensation altering effects of MDMA (increased desire for and enjoyment of intimacy/physical contact/tactile experiecne). Don't blame Ed for the "female Viagra" characterization, I've seen it elsewhere too.
Forgot to officially state that neither the new drug nor MDMA can be considered safe. And of course neither is legal to use.
Isn't this the second time it's been turned down? Obviously not enough money has changed hands.
yes, M Helm, I agree. I'm not blaming Ed for anything, only requesting he not perpetuate a false comparison. yet, in my understanding, if flibanserin worked half as well as MDMA, it would have done much better in the clinical trials. just sayin'
Harpy,
I feel the same way about "atypical" antipsychotics. The only thing atypical about them is their ability to add metabolic problems to the other more mundane neurologic complications of older antipsychotics. I would be happier with a label of "newer" antipsychotics or even "brand-name" antipsychotics. Of course, with my (patient safety-oriented) mind-set "newer" modifying a medicine or category is synonymous with "riskier" and "less-studied."
There needs to be a general category which means the same thing as "pharmacologically active compounds purporting to treat an alleged medical condition," don't you think?
indeed! how about "nostrum"? it's old enough to be brand new again.
Beautiful - I concur!
Here's hoping Ed will push "nostrum" into more common usage!
Here is an article from the UK that may answer a question or two:
http://www.independent.co.uk/life-style/health-and-families/us-panel-rejects-female-viagra-2006069.html
US panel rejects 'female Viagra'
AFP
Sunday, 20 June 2010
An advisory panel for the US Food and Drug Administration Friday voted unanimously against approving a pill that helps boost women's sex drive, described by some as the "female Viagra."
The FDA's Reproductive Health Drugs Advisory Committee said the evidence presented had not demonstrated the effectiveness or safety of flibanserin, made by the German company Boehringer Ingelhein.
"The efficacy was not sufficiently robust to justify the risks," said panel chair Julia Johnson, chief of obstetrics and gynecology at the University of Massachusetts Medical School, after the committee's deliberations.
The FDA usually follows these panels' advice, even though it is not required to do so by law.
Flibanserin, the latest effort to come up with a female counterpart to the wildly popular male erectile dysfunction pill Viagra, works on brain chemicals to treat pre-menopausal women with a low sex drive, according to the maker.
To date, the drug known by the commercial name Girosa has not been approved for sale in any country, in contrast to treatments for male sexual dysfunction.
Pharmaceutical firms have vied for a spot in this potential market estimated to be worth two billion dollars since Viagra was launched in 1998 becoming a huge success, and was subsequently followed by competitors Cialis and Levitra.
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 big pharma has 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" (Hypoactive Sexual Desire Disorder), the report 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.
According to the studies cited by FDA, flibanserin can also cause side effects such as depression or dizziness.
Flibanserin belongs to a family of anti-depressants 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.
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The mind reels at being subjected to those endless commercials for "erectial Dysfunction" being turned towards marketing a drug for women women.