TORONTO (CP) - A short-acting version of a drug used to treat depression helps alleviate premature ejaculation in those severely affected by the condition, improving sexual satisfaction for both the men and their female partners, U.S. researchers say.
Their multicentre study of more than 2,600 men with the problem found the experimental drug dapoxetine increased time before ejaculation during sexual intercourse by three to four times, depending on the dose.

Dapoxetine belongs to a class of drugs known as selective serotonin re-uptake inhibitors (SSRIs), which are widely prescribed for depression and include such brand names as Prozac, Paxil and Zoloft. Dapoxetine was specifically developed for premature ejaculation, based on a side-effect of delayed ejaculation associated with its longer-acting SSRI cousins.

"This is the first drug especially targeted towards premature ejaculation, which is a common problem," said principal investigator Dr. Jon Pryor, a urologist at the University of Minnesota. Up to one-third of men of all ages are chronically plagued by the condition, which results in an inability to control the timing of orgasm.

"We tend to think of this as, 'Oh, it affects novices, the first time, and young people,' " Pryor said Thursday from Minneapolis.”But no. There are some people who have this who are older, and oftentimes it affects them their entire lives."

While some men may not be too bothered by the condition, he said, "for other people with premature ejaculation, it's devastating. It has effects that go beyond just the bedroom and it affects their self-confidence and self-esteem."

The researchers, whose results were published in Friday's issue of The Lancet, randomly split the 2,614 participants into three groups. Those in the first group received a dummy pill, while men in the other two groups took either 30 milligrams or 60 milligrams of dapoxetine. Neither the patients nor the researchers knew who had been assigned which dose or the placebo.

The men, whose average ejaculation time from vaginal penetration was less than one minute, were advised to take their pill one to three hours before having sex. Only one pill was to be taken in any 24-hour period. Ejaculation was timed using a stopwatch operated by their female partners. (Only men in stable relationships for at least six months were included in the study.)
By the end of the 12-week trial, the average time to ejaculation rose to 1.75 minutes for men on placebo, 2.78 minutes for those taking 30 milligrams of dapoxetine and 3.32 minutes for participants given 60 milligrams of the drug.

"For a lot of these patients, this was like utopia," said Pryor. "Here's something you take whenever you want to have intercourse, like an hour or so before, and it had a low incidence of side-effects. And all of a sudden, they were lasting three; four times what they were before."
"Also, just as important, was the fact that there was an improvement in (perceived) control over ejaculation and also satisfaction with sexual intercourse both for the subject, the man, as well as his partner."

Dr. Laurence Klotz, head of urology at Sunnybrook Health Sciences Centre in Toronto, called the findings a potential advance for men with a severe form of the sexual dysfunction.
"The caveat would be that this is not for your average guy who wished that he could last longer," he said. "This is for patients who basically ejaculate almost as soon as they start having intercourse. And that can be a real problem."

Klotz said the cause of premature ejaculation is multifactorial, partly psychological and partly a function of everyday differences among human beings. Treatment involves physical behaviour modification; including switching traditional positions so the man is on the bottom during sex.

"And I guess they close their eyes and think of Queen Victoria, a sort of psychological technique to take their mind off what's happening," he added.

Dapoxetine is being developed by ALZA Corp., a division of Johnson and Johnson, which funded and designed the research - two studies conducted at 121 centers across the United States. Pryor said the researchers had complete control over reporting the results and writing The Lancet paper.

Still, the drug maker has much to gain if regulatory bodies such as Health Canada and the U.S. Food and Drug Administration grant approval for dapoxetine to be prescribed for widespread use. Some put the estimate at US$500 million a year in sales.

While Klotz doesn't believe the drug represents "the further medicalization of sex" by the pharmaceutical industry, Dr. Jim Wright of the University of British Columbia isn't so sure.

The internist and clinical pharmacologist said SSRIs for depression can have significant side-effects - including preventing ejaculation entirely - and they carry warnings about increasing suicidal thoughts and possibly violent outbursts in some patients.

"My first reaction is: Should we be using a side-effect of a drug for another indication?" Wright said from Vancouver. "And potent drugs that we're still learning about but that we're concerned about in terms of their major side-effects, including increasing the risk of suicide."

Pryor wants the drug - or others that work in the same way - to do for premature ejaculation what Viagra and similar medications have done for erectile dysfunction.

"To me, as a physician in this area and an academic, deep down what I'm hoping is that it's going to increase the interest and understanding of premature ejaculation and give people hope."

"When Viagra came out . . . it brought ED out of the closet and it got people to talk and it stimulated interest in the field."

"I'm hoping the same thing happens with this."

In a commentary, Italian urologists Dr. Francesco Montorsi and Andrea Salonia say they believe most men with the condition "would clearly prefer on-demand treatment compared with being placed on a drug long-term."

"Our hope is that on-demand dapoxetine will become an important drug to offer patients with premature ejaculation," write Montorsi and Salonia of San Rafael Hospital in Milan, neither of whom was involved in the study.

Source::
http://www.cbc.ca/cp/health/060907/x090720.html