Erectile dysfunction answers fresh news.

Sept. 7, 2006 — The first drug developed specifically for premature
ejaculation performed well in two clinical trials, but the new treatment
probably won’t be available in the U.S any time soon.

Men in the study who took the experimental drug Dapoxetine, developed by
Johnson & Johnson Pharmaceuticals in with ALZA Corp., were able
to maintain erections longer than men who took placebos.

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) but is
slightly different from the SSRIs (such as Zoloft, Paxil, and Prozac) widely
prescribed for depression and other
disorders.

The drug was designed to be taken as needed, one to three hours before sex,
instead of every day. Also, it is eliminated from the body more quickly than
other SSRIs.

Hopes that Dapoxetine would become the first drug approved for premature
ejaculation dimmed last October, when the FDA sent a “not approvable”
letter to the manufacturer.

The FDA’s concerns about the drug were not made public. In a news release,
ALZA Corp. promised to “address questions raised in the FDA
letter.”

A spokesperson for Johnson & Johnson told WebMD Thursday that the
company “remains committed to the global development” of
Dapoxetine.

A Common Complaint

Although it is rarely talked about, premature ejaculation is a common
problem, affecting as many as a third of men.

Far fewer men seek treatment, however.

Those who do are often advised on practice techniques to help. Some receive
a prescription for a traditional, long-acting SSRI, since delayed ejaculation
is a common side effect among men who take SSRIs for depression.

This use of traditional SSRIs would be considered off-label since the
medications are not specifically indicated for this problem.

Other potential sexual side effects of SSRIs include erectile
dysfunction and loss of libido, however, making the traditional
antidepressants less than ideal for treatment of premature ejaculation, Jon L.
Pryor, MD, tells WebMD. Pryor is a urology professor at the University of
Minnesota.

Sex

In the manufacturer-funded study, Pryor and colleagues compared 30-milligram
and 60-milligram doses of Dapoxetine to a placebo in roughly 2,600 men with
moderate to severe premature ejaculation.

Prior to treatment, the men’s average ejaculation time was just under a
minute.

With treatment, the average time to ejaculation was 1.75 minutes in the
men, 2.78 minutes in the men treated with 30 milligrams of
Dapoxetine, and 3.32 minutes in the men treated with 60 milligrams of the drug.
The study lasted three months.

“A couple of minutes may not sound like much but for these guys it was
huge,” Pryor says.

Men who took the short-acting SSRI also reported having more control over
their ejaculations than the placebo-treated men; and they and their female
partners reported improved sexual .

The Snicker Factor

Pryor says an effective, specific treatment could do for premature
ejaculation what Viagra did for erectile dysfunction
– taking away the ’snicker’ factor by stimulating open discussion about the
disorder.

“Viagra wasn’t a magic pill, but it did bring ED into the open and men
who had it learned that they were not alone,” he says. “The discussion
that followed stimulated research that led to other treatments.

“Premature ejaculation is more common than ED, but no one talks about
it,” adds Pryor.

Ira Sharlip, MD, a urology professor at the University of California, San
Francisco, tells WebMD there is a definite need for an effective treatment for
premature ejaculation.

“I have patients who are really disturbed by this issue, and so are
their wives,” he says. “The current treatments are far from
perfect.”

Sharlip says traditional SSRIs work best when they are taken every day, and
even then they only work for around two-thirds of patients.

“Premature ejaculation is certainly one of the most common forms of
sexual dysfunction among men,” Sharlip says. “Not everyone who has it
is bothered by it, but for those who are, it can be a very big
problem.”