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Dapoxetine

Dapoxetine is the International Nonproprietary Name of a drug currently being considered for approval by the FDA for the treatment of premature ejaculation in men, which would make it the first drug approved for such treatment. It is currently in Phase III of the approval process. This would make it join the ranks of sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®), the erectile dysfunction drugs, as a drug intended to improve male sexual health. more...

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Dapoxetine, submitted to the FDA in the form of dapoxetine hydrochloride, was developed by ALZA Corporation and its parent company, Johnson & Johnson.javascript:insertTags('','','Insert formula here'); Mathematical formula (LaTeX)

Like other drugs in this category, it is controversial for turning something that is traditionally considered psychological into a physiological problem that can be treated, to the benefit of the pharmaceutical industry (but also to the people with the dysfunction).

In October of 2005, the Food and Drug Administration issued a nonapprovable letter for Dapoxetine.

Read more at Wikipedia.org


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Drug firms look for treatment for premature ejaculation
From Chicago Sun-Times, 7/4/04 by Jim Ritter

The drug industry, which has done a masterful job convincing men to get help for impotence, is looking to the next frontier in male sexuality -- premature ejaculation.

Johnson & Johnson, the big drug manufacturer, plans to ask the federal Food and Drug Administration next year to approve a pill for premature ejaculation, which, by various estimates, affects 20 percent to 30 percent of men at some point in their lives.

Another company is developing a cream that's placed into the tip of the penis.

"There's a lot of interest in the area of premature ejaculation," said Dr. Laurence Levine of Rush University Medical Center.

The condition generally is defined as ejaculation that occurs either before intercourse or within one or two minutes of penetration. When asked by researchers, men typically say they spend 10 to 15 minutes in sexual intercourse. But guys tend to exaggerate, said Dr. James Barada of the Albany Center for Sexual Health.

A few small studies, in which wives used stopwatches, found that intercourse typically lasts four to seven minutes. But those studies had small sample sizes and other flaws, Barada said. Bottom line: No one really knows what the norm is. Barada is trying to find out in a stopwatch study of 1,000 men.

Premature ejaculation might be the butt of jokes in movies such as "American Pie" and sitcoms such as "Friends," but, in real life, it "can be quite devastating to the sexual intimacy of the couple," said New York University urologist Dr. Andrew McCullough. A survey of 1,239 men by McCullough and colleagues found that premature ejaculators were less satisfied with sexual intercourse, more likely to have trouble getting aroused and less likely to be relaxed during sex.

The problem affects people differently. Some of the men McCullough treats are dragged in by their frustrated partners. With other couples, the man seeks treatment, even though his partner isn't bothered.

Doctors are finding that drugs approved for other conditions can treat premature ejaculation. Lidocaine, an anesthetic skin cream often used to ease the pain of shingles, can delay ejaculation when applied to the penis. But men generally don't like the reduced sensitivity. And unless the man wears a condom, the cream will rub off and numb his partner, too.

Viagra sometimes helps. Some men can't maintain an erection for long, so they hurry up in what one patient calls a "two-minute drill." Viagra and two new competing drugs, Levitra and Cialis, can prolong the erection, thereby allowing the man to slow down. And after ejaculation, Viagra can help a man get a second erection, which tends to last longer before ejaculation. But a 2000 study sponsored by the maker of Viagra found it did not have a large benefit on premature ejaculation.

A class of antidepressants known as SSRIs -- which includes Prozac, Paxil and Zoloft -- can delay ejaculation. Some male users find they either can't reach an orgasm, or take so long that sex becomes work.

But for men who suffer premature ejaculation, this side-effect can be desirable. Still, the drugs are slow to take effect. A man has to either take the pill four to eight hours before having sex, or take the drug every day. And SSRIs have other possible side-effects, including nausea, dry mouth, drowsiness and reduced sex drive.

An SSRI that failed as an antidepressant is showing promise as a premature ejaculation drug. Johnson & Johnson is developing a version of the drug, dapoxetine, that kicks in after only an hour or so. A small study of men with premature ejaculation found that 40 percent who took the drug reported their level of sex satisfaction was good or very good, up from 15 percent before treatment. A larger study is under way.

Farther down the road is an anesthetic cream being developed by NexMed. The patient would use an applicator to apply a drop or two into the opening of the penis. The company says the drug slows excitation without numbing. A small study found it increased the length of intercourse to four minutes from one minute. Side-effects include a tingling or warming sensation.

The drug wears off quickly, so it would have to be applied just before intercourse.

"It could affect the spontaneity," said NexMed vice president Kenneth Anderson.

Non-drug treatments

*Individual or couple therapy

*Stop-start method. When the man feels an ejaculation coming on, he pulls out. He or his partner squeezes the end of his penis for several seconds. He waits half a minute or so, then resumes.

*Think about something else, such as Cubs or Sox starting lineups.

*Wear a condom.

*Some young guys masturbate before dates, figuring they will last longer on their second erection.

*Learn to live with it. A New York University survey found that about one half of the men who said they ejaculated before they wished considered it no big deal.

Copyright The Chicago Sun-Times, Inc.
Provided by ProQuest Information and Learning Company. All rights Reserved.

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