The Telegraph
Since 1st March, 1999
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Delayer drug passes a test
- Formulation to treat bedroom woes works in trials

Washington, May 24 (Reuters): The first drug formulated to treat premature ejaculation delays climax and also increases reported satisfaction, researchers said.

The drug, called dapoxetine, helped men delay their orgasms significantly and doubled the numbers of men and their female partners reporting “good” sexual satisfaction, they told a conference.

“Premature ejaculation is a really common problem, affecting between 10 and 30 per cent of all men. Here is something for the first time that we have that works,” said Dr Jon Pryor, chairman of the department of urologic surgery at the University of Minnesota, who led the study.

He said the drug worked quickly and with few side-effects.

“It gets in rapidly. It gets out rapidly. You can take it one to three hours before intercourse,” Pryor said in a telephone interview.

The drug is being co-developed by Mountain View, California-based Alza Corp. and Johnson & Johnson Pharmaceutical Services LLC. Ortho Pharmaceutical will market the drug in the US if it receives Food and Drug Administration approval. All three companies are units of Johnson & Johnson .

[Usually, it takes about two-three years for a drug to reach India from the time of FDA approval.]

In a study presented to a meeting of the American Urological Association in San Antonio, Pryor said men who took dapoxetine at doses of either 30 mg or 60 mg had a three to four-fold increase in ejaculation time compared to men given a placebo.

The percentage of men rating control over ejaculation as “fair to very good” increased from 2.5 per cent before getting the drug to 51.8 percent afterwards for men who got the lower dose, and 58 per cent of men given the higher dose.

Of the men who got the placebo, 3.5 per cent reported fair to very good control before getting the dummy pill and 26.4 per cent said so afterward.

“The percentage of men rating sexual satisfaction as ‘good to very good’ almost doubled with dapoxetine 30 mg (20.2 per cent to 38.7 per cent) and 60 mg (22.3 per cent to 46.5 per cent),” the company said.

Just under 25 per cent of men who got the placebo reported good sexual satisfaction.

Only about 20 to 25 per cent of the men’s partners felt satisfied by sex before the men took the drug but this doubled to 47 per cent after the men took the highest dose.

The trial was a phase III clinical trial of 2,614 men, designed to be the last test before seeking FDA approval.

It is a drug called a serotonin transporter inhibitor.

“We know that you need serotonin to ejaculate,” Pryor said. But he said no one truly understood how ejaculation works, or precisely how the drug affects serotonin, an important message carrying chemical used by nerve cells.

The companies have worked hard to define just what premature ejaculation is in order to set parameters for testing the drug.

But they anticipate a good market.

The American Urological Association estimates that premature ejaculation affects anywhere between 27 per cent and 34 per cent of men across all age ranges. Erectile dysfunction, the condition that made Pfizer’s impotence drug Viagra into a blockbuster, affects an estimated 10 per cent to 12 per cent of men.

Researchers working on the drug reported last month that they could define premature ejaculation. They said a man with the condition took 1.8 minutes to ejaculate after beginning intercourse compared to 7.3 minutes for most men.

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