The Female Viagra Pill Failed To Boost Desire: FDA
13 CommentsBy Ed Silverman // June 16th, 2010 // 10:45 am
File this under ‘from hot to cold.’ On the eve of what will be a closely watched and controversial FDA advisory committee meeting on Friday, a team of agency reviewers found the Boehringer Ingelheim pill, which is called flibanserin and was tested to treat Hypoactive Sexual Desire Disorder, failed to meet agreed-upon criteria to establish effectiveness in two company studies.
Specifically, there was no statistically significant improvement on the co-primary endpoint of sexual desire, although the pill did show a statistically difference in generating sexually satisfying experiences compared with a placebo (read the report here).
The FDA Division of Reproductive/Urologic Drug Products cited several points of “major concern” heading into the meeting: The trials didn’t show a statistically significant difference for desire. Also, BI’s request to use the Female Sexual Function Index desire items as an alternative tool to evaluate sexual desire wasn’t statistically justified or supported by exploratory data from one study, which also failed to demonstrate a statistically significant treatment benefit on desire using the FSFI desire items.
Responder rates on important efficacy endpoints for patients taking the pill, which were intended to demonstrate clinical meaningfulness, were only 3 percent to 15 percent greater versus placebo. And the reviewers wrote “there were many significant medical and medication exclusion criteria for the efficacy trials, so it is not clear whether the safety and efficacy data from these trials are generalizable to the target population for the drug.”
In fact, women who did take certain prohibited concomitant medications had higher rates of adverse events. Tolerability, meanwhile, was only moderate and adversely affected when also using SSRIs, triptans, and hormonal contraceptives, or when drinking alcohol. Despite these concerns and limitations, there is great interest in the pill, especially since there is no drug in the US currently approved to treat HSDD which, itself, is debated as something that can be alleviated with medication. And it’s still not clear how flibanserin works. What do you think?
Should the Female Sexual Dysfunction Pill Be Approved?
- No (63%, 96 Votes)
- Yes (37%, 57 Votes)
Total Voters: 153
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in-house
Maybe the primary endpoint should have been “sexually satisfying experiences.” Although it may not increase the number of times that a woman is insterested, at least when they were interested, it was satisfying.
Men need all the help they can get.
Carrie
Bremelanotide FTW !
…then PL-6983… then an oral administration of the formula from Palatin Technologies.
:)
MsPiggy
I gather from this FDA thumbs down; desperate men & sock puppet perverts will just have to stick with internet dating and slipping knock-out drugs into drinks at bars until Pharma can rectify this situation.
Edward
Good - this would have just distracted the industry from research on a pill that can talk to girls for me and make them like me.
harpy
was this drug ever tested on men?
Stephany
Here is an alarming twist on this topic:
WOMEN you need to stand up and be heard!
http://tenured-radical.blogspot.com/2010/06/call-1-800-femnist-or-will-unnecessary.html
“pediatric urologist Dix Poppas (who holds a named chair at Weill Cornell Medical Center at New York Presbyterian Hospital) is performing clitoral reduction surgeries on little girls. Presumably, because none of the subjects is identified as having a dangerous condition”
m Andrea
The first comment says it all. “Men need all the help they can get.” This drug isn’t for women, it’s for men who think they’re entitled to as much sex as THEY want.
Viagra doesn’t help with desire so much as helping the penis stay hard; men already had the desire. But this drug isn’t so women can have sex — their equipment already works. This drug is so that men can justify their entitlement to sex by first nagging their wife or gf into taking the pill by whining how they’re not getting enough of the sex to which they feel they are entitled, and then saying “oh since you’re horny now then let’s have lots of sex”.
Do you freaking morons think women are so stupid that they don’t realize who this pill is really for? And is it any wonder that this pill doesn’t have the entended effect? NO pill is going to make the majority of women appreciate your goddamned entitlement attitude. What you assholes want is a Stepford Wife. Do the dishes and clean up after yourself on a regular basis, quit treating your wife or gf like you think she’s only there to serve you — that’ll be more effective than any pill.
m Andrea
It would be interesting, not to mention incriminating, if someone were to do a study on the motivation of the women taking this pill. Was this something she came up with all on her own, or was she doing it because she has some moron at home whining about all the sex he is entitled to?
Because you know, people who lack the desire to perform some activity, don’t WANT or NEED the desire to perform that activity — unless there is a negative repercussion nagging them in the background.
m Andrea
Apologies for serial posting, but lots of women would love it if their husband or bf would take a pill to become a decent human being.
Josh
And vice-versa….
David ajibola
HSDD could be a very devastating condition to a woman physically,mentally and socially.With the failure of this drug I can assure you many women are lapsing into a state of despair already,but here is the good news,as a medical researcher, I am currently working on a new and promising drug in this regard.You can be on the lookout!
industry insider
David, while we’re on acronyms there’s an even more serious condition in men than HSDD in women, often seen in the urologists office today in men whose wives have HSDD:it’s called DSB-Deadly Semen Backup. With DSB some men develop autoantibodies to proteins found in semen, and the resulting backup can have devastating health consequences.
Viagra is the answer to DSB.
Other John
m Andrea, you wouldn’t be interested in going out this Saturday night by any chance?