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Old 11-07-2006, 07:58 PM   #1 (permalink)
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Why didn't the FDA approve this drug?

http://www.msnbc.msn.com/id/14717055/

Quote:
LONDON - A drug designed to treat premature ejaculation works well and is safe, researchers said on Friday.

Dapoxetine, an antidepressant known as a selective serotonin reuptake inhibitor (SSRI), is the first treatment specifically for premature ejaculation.
Quote:
Last October, the U.S. Food and Drug Administration declined to approve the drug. The company said it would continue to develop the treatment and would address questions raised by the FDA.
Now, I have taken SSRIs and this was one of the side effects. It didn't do anything for me in terms of satisfying a woman since I was single, and it was even kind of hard to reach orgasm every once and a while. But, I did have to take it everyday (which kept the headaches and dizziness side effects away). That is the only medical reason that I could see why the FDA didn't approve it. I guess the fact that you would have 2/3rd of the men in this country taking some kind of drug before having sex might be another problem. (1/3 taking Viagra, the other 1/3 taking this to last longer)
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Old 11-07-2006, 08:03 PM   #2 (permalink)
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Only the FDA knows the true answer.
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Old 11-08-2006, 06:19 AM   #3 (permalink)
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Quote:
(1/3 taking Viagra, the other 1/3 taking this to last longer)
I would take both. Not that I need to, but any little edge helps right?
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Old 11-08-2006, 08:17 AM   #4 (permalink)
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A drug for premature ejactulation?

That has to be the biggest example I've seen yet of a drug marketed to fix a problem that is COMPLETELY fixable on it's own. Good job for the FDA not approving it.

Guys, women don't want a man who's on viagra for the fuck of it. We don't want a man who's supressing his premature ejaculations with drugs. We want men who are HONEST AND REAL and perhaps mature enough to deal with their problems instead of medicating them away.

If I was dating someone and found out they were taking either viagra or a "performance enhancer" (like one to stop premature ejactulations) recreationally I would most likely drop him like a hot rock. Come to terms with your penis size, deal with your "erection" issues, learn to please a woman in bed naturally, and quit being pussified into medicating your "problems" away.

$0.02
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Old 11-08-2006, 08:31 AM   #5 (permalink)
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for the most part i agree with sage, if you dont need the drug, dont take it. some people do have medical conditions such that they need drugs to fix there problems.
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Old 11-08-2006, 08:57 AM   #6 (permalink)
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Sage and Dilbert are right. I've been with one man that took Viagra. It was horrible. Guess what guys? we don't really want a man to last hours and hours, frankly sex gets boring after too much time. About 30 minutes, 45 tops! After that it gets to the point of thinkikg, "hmm did I remember to stick Aunt Fannie's birthday card in the mail?"

If I were attracted to the energizer bunny, I would be dating him ok? I'm not, so don't try to be like him.
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Old 11-08-2006, 09:14 AM   #7 (permalink)
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Quote:
Originally Posted by Sage
Come to terms with your penis size, deal with your "erection" issues, learn to please a woman in bed naturally, and quit being pussified into medicating your "problems" away.
For once, I'm going to take the "to each their own" position. No offense, but you lose all penile credibility simply because of your gender. These are pretty complex tools we've got here, and you're making an argument that we should be able to fix something like a car engine simply by the power of our thought.

There's a great deal of cognitive dissonance here, simply becuase I attribute many problems like depression to purely mental causes. However, I think we're not just talking about a "mental" issue, Sage. Every man, and consequently every penis, can be different. Some people recieve less blood, some people recieve more. Some are stimulated much more quickly, some are stimulated more slowly. This is exacerbated by the fact there are tens of millions of people who no matter how much they will it, cannot miraculously create an erection. The blood simply isn't there.

I happen to be about the middle of the road when it comes to duration, but I wouldn't put it past someone to last five seconds if it felt really good. I wouldn't say this is really a problem, but some women would. If they're asking (and rightfully so) for a longer duration, then why would a drug that assists them be a problem?

The way I look at it, premature ejacuation is either:

(a) genitals are too sensitive
(b) partner is incredibly attractive, new, or trying something new
(c) man is incredibly aroused prior to intercourse (lots of foreplay)

A can be fixed by this drug or masturbation. Just because I opt for the latter doesn't mean someone shouldn't be given the opportunity to opt for the former. Further still, masturbation may not be enough. Enter this drug.

B may diminish with time. If it it does not, then the solution is either the drug or beating the woman with an ugly stick until he is no longer attracted to her.

C can be limited, knowing the condition.
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Last edited by Jinn; 11-08-2006 at 09:17 AM..
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Old 11-08-2006, 09:21 AM   #8 (permalink)
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Quote:
Originally Posted by Sage
If I was dating someone and found out they were taking either viagra or a "performance enhancer" (like one to stop premature ejactulations) recreationally I would most likely drop him like a hot rock.
Why? Why wouldn't you help him overcome his dependence?

Quote:
Originally Posted by Sage
come to terms with your penis size
"Does my penis look small?" is about the same thing as "does this dress make me look bad?" It's a self-esteem issue and can be very difficult to overcome and requires a lot of reassurance from a partner. How would you feel if you asked your partner, "Do you think this dress makes me look bad?" and she/he replied, "You just need to come to terms with it."

Quote:
Originally Posted by Sage
learn to please a woman in bed naturally
This is part of the problem. It's not about pleasing a woman in bed. It's about pleasing each other. Each partner is equally responsible for their own "pleasure" as much as for their partners pleasure. That's one key to overcoming premature ejaculation.

There is too much pressure for men to "perform." More women need to learn to be equally responsible for their own orgasm.

<b>As for the topic of this post:</b> The drug does NOT address the issue which is, "Why is the patient prematurely ejaculating?" If you identify the cause, then you can work on a drug-free way to overcome it. That's most likely why the FDA did not approve this drug. The potential for abuse is much higher in drugs like this; which we've seen with Viagra.

However, Viagra DOES treat a real physical problem: erectile dysfunction. Viagra was NEVER meant to be used recreationally so guys could "go all night." It was meant to be prescribed for men who could not physically maintain an erection. Not because of psychological reasons ... PHYSICAL reasons.
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Old 11-08-2006, 09:44 AM   #9 (permalink)
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Maybe the FDA finally grew a pair and denied the company from cross-prescribing. It's ridiculous how many drugs are just milked for new applications. In my opinion a drug that was developed as an SSRI anti-depression shouldn't be marketed for what is essentially a side effect.

How do you define premature ejaculation, anyway? How common is it? The mental picture I get is some Woody Allen type character who can't make it past the first kiss. I thought that was mostly curable through experience.
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Old 11-08-2006, 09:45 AM   #10 (permalink)
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I need a drug that will let me ejaculate faster. Gimme a little more sensitivity gimme a little more craving. I can go on forever sometimes it sucks. My stomach hurts my arms are all shaky dripping sweat in my girl freinds eyes ugh it's just bad experience for everyone.
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Old 11-08-2006, 09:54 AM   #11 (permalink)
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Quote:
Originally Posted by hrandani
How do you define premature ejaculation, anyway? How common is it? The mental picture I get is some Woody Allen type character who can't make it past the first kiss. I thought that was mostly curable through experience.
Here's the abstract from a Medsearch article:

Quote:
Premature ejaculation (PE) is likely the most common sexual dysfunction in men, with a worldwide prevalence of approximately 30%. To date, the lack of a universally acknowledged definition of PE has complicated the examination and analysis of PE in clinical and research-related settings. The impact of PE on men and their partners also needs to be clearly defined. Clearly, a better understanding of the epidemiology of this disorder, especially with regard to prevalence and risk factors, is necessary. The prevalence of PE appears to vary across socio-cultural and geographic populations. The elucidation of the etiology of PE and risk factors associated with PE has been difficult. However, several risk factors for PE exist that have strong support in the literature. Clearly, an improved and universal definition and understanding of PE and its epidemiology will improve the clinical management of PE and the success of future epidemiologic studies and clinical trials.
Unfortunately, I don't have access to the entire article. The library here doesn't have a copy.

Make no mistake, it IS a problem beyond first-time jitters in a lot of men.
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Old 11-08-2006, 06:24 PM   #12 (permalink)
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But, this drug would help relationships. I would think that the guys would go on anti-depressants anyway after their girl left him because he could only last 1 or 2 minutes. I am probably in the 2-4 minute range for the first orgasm, and another 2 minutes for each one after until about 10-12 minutes. I'm not complaining about this for myself. But, if I was a guy and could only last 2 minutes (or less), it would be a problem.

When I was on SSRIs, I went up to the 6-8 minute range for the first, 5-7 minutes for the second one, and I was too tired to go any further.

I would think that the side effects of headaches would be really common, and I'm not sure what would happen if 30% of the male population was on SSRIs almost everyday (how long does it stay in your system).

Off topic, The other side effect that wasn't so bad was the dreams I had were so real, when I woke up, I couldn't remember if I had done something in real life or in the dream.
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Old 11-08-2006, 07:47 PM   #13 (permalink)
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Ok, I know I came across a bit harsh in that first post, so I'd like to clarify a bit.

I think that jumping at a drug, whatever it is, to treat any problem you are having (essentially "self-medicating" your problems away) is lame. That's what I am so vehemently against, the tendency for people to just rely on drugs and nothing else to take away all their issues.

However, after thinking about things a bit more, I realize that I'm OK with this drug, IF a man first tries to deal with PE on his own, then goes to his physician to rule out any physical reason, and then goes to a thearapist to rule out any mental reason. Then, and only then, do I understand the need for the drug. Unfortunately, that is often not the case, and people aren't usually interested in getting down to the cause of the problem, they're just looking for a "quick fix" to get the problem to go away.

I also want to include the caveat that I am wary of drug companies to begin with because of my negative expierence with birth control and the reluctance of doctors to recommend IUD's to women, preferring to use drugs which can and do cause mental and physical problems.
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Old 11-08-2006, 10:18 PM   #14 (permalink)
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Because this drug wasn't created in America, and the medical trials weren't done in America. That's the short answer.

Selective Serotonin Reuptake Inhibitors are not drugs to be taken lightly. They alter the chemistry of the brain. For a person suffering from depression, this can be a helpful change so they can have a better quality of life. In everyone else, it's changing the chemistry of your brain to have better sex. While that may improve the quality of life, it's the FDA's job to be sure that the risks do not outweigh the benefits.

Also, just because a drug is approved somewhere else in the world, doesn't mean it will fit the mold set by the FDA- so there's never any point in saying "well it's ok over there...". This has nothing to do with being better than anyone, it has to do with strict quality and safety control. Britain's is very good as well, in my understanding, but all the British medical trials in the world won't force the hand of the FDA. They need to do their own, to be as sure as they can be that what they approve is safe for use.
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Old 11-21-2006, 05:13 AM   #15 (permalink)
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Perhaps a bit late to reply... but I was upset with the statements...

1) Medication, also for sexual disorders, should be available.
If you need viagra because otherwise 'it' will not work, you have a legitimit reason.
If you have premature ejaculation and only last 10 seconds (yes... seconds) then medication is justified.
Ofcourse, if you already last 10 minutes... viagra or something else is not because of a medical disorder.... then you suffer of something else....

2) Women do see the need also for medication if the partner is in the above situation. If you can not penetrate, because of no erection, or premature ejaculation, they will even insist on medication

3) OK, there are couples who can exist without sex, but more couples will 'break' because of no sex, if the woman wants it and the man can't....

4) Please make a distinction between those who have a real problem, and those who don't.
Because the messages as above, makes it even more difficult (taboe) for the men with REAL problems

regards,
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Old 12-02-2006, 04:07 PM   #16 (permalink)
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The FDA knows very few true answers, and those that they ascribe to ain't necessarily so. I'm unqualified so I'm saying nothing, but I stand by what I said, so your aim should be good! LYA!
Probably medication, being artificial, would be a bad place to go. What thoughts have you had about your penis and your thoughts about it? At least those thoughtlines might be more "holistic"? Maybe.
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Old 12-02-2006, 08:35 PM   #17 (permalink)
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Quote:
Originally Posted by analog
Also, just because a drug is approved somewhere else in the world, doesn't mean it will fit the mold set by the FDA- so there's never any point in saying "well it's ok over there...". This has nothing to do with being better than anyone, it has to do with strict quality and safety control. Britain's is very good as well, in my understanding, but all the British medical trials in the world won't force the hand of the FDA. They need to do their own, to be as sure as they can be that what they approve is safe for use.
Incorrect, the FDA accepts any trial, in the past few years frequently companies are being set up to run trials in India and China, seeing as how it is a royal bitch to get enough willing guinea pigs in the states.

See Body Hunters: How the Drug Industry Tests Its Products On the World's Poorest Patients: Books: Sonia Shah
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Old 12-05-2006, 09:38 AM   #18 (permalink)
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Quote:
Originally Posted by Crack
I would take both. Not that I need to, but any little edge helps right?
When you cross the line from stud to sexual automoton...
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Old 12-06-2006, 06:18 PM   #19 (permalink)
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Quote:
Originally Posted by Crack
I would take both. Not that I need to, but any little edge helps right?
That is probably why they didn't approve it. They see how many people are taking Viagra without a reason to, and were worried that the same thing would happen witth this drug.
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Old 12-07-2006, 10:14 AM   #20 (permalink)
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to sage, as a guy, there is always a desire to provide the best performance possible for my SO...and despite how much foreplay I try to provide, after a while, she just wants "it". as of late, i have been trouble lasting long enough for my or her enjoyment...dont know why.

I've gone so far as to try to think about what general maintenance I need to perform on my car next and planning my day while having sex...didnt stop the "too soon" problem.

Im sure the actual problem is that we can only see each other once a week, so by that time, im on a short fuse....but I dont get a whole lot of chances to practice...so I think that next time, i'll just use an extended pleasure condom and be happy.
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Old 12-07-2006, 12:00 PM   #21 (permalink)
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In my book, popping Viagra when you don't have an erectile dysfunction is akin to getting a boob job "just to have bigger ones".

If the latter is a major turn-off for me, I can't blame a girl for not wanting a guy who's popping pills just so he can pretend to last like a porn star.
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Old 06-25-2007, 01:21 AM   #22 (permalink)
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to each his (or her) own... imho i think there is a case for both mental and physical and chemical approaches to health and performance. from what i have read, dapoxetine is a short acting ssri and the risks from trying it before sex on occasion would be minimal. i have tried it at the low dose done in trials and it definitely made me last a lot longer... without reducing sexual drive or pleasure.. the only other effect was a slight relaxation. i think it might really help some guys and give them the 'space' to learn other things without the pressure of coming too fast. anyhow if you are interested i can send you to a site where there is a report about it with sources for small orders.
Whatever, it's not a good condition so good luck with your journey to be better in bed.. i think this is as legitimate an endeavour as being better at anything!
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Old 06-25-2007, 05:14 AM   #23 (permalink)
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um... you're asking for a place that sells drugs?
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