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Waiting to Expel

I was reading in yesterday's Wall Street Journal (copied below the fold) about the ongoing research into treating premature ejaculation as a "disorder." In the absence of drugs designed for the purpose, SSRI antidepressants such as Paxil and Zoloft are being prescribed; the new drugs in the pipeline are also SSRIs, even though SSRIs are known to have "sexual side effects such as damping libido."

So, you will last longer before orgasm, but won't enjoy it very much.

One drug under development, dapoxetine, also causes nausea. So let's tally this up; with these treatments: It takes a while to reach orgasm. The sex isn't particularly enjoyable. And you get nauseous. It sounds like they are trying to turn men into women. (Or at least the women I've dated.)

The Next Wave of Sex Drugs; In Wake of Viagra, Pharmaceutical Industry Targets Another Male Malady

By JANE SPENCER and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
May24,2005;PageD1

The drug industry has made billions by taking the stigma out of the once-taboo subject of erectile dysfunction. Now, it is targeting an equally delicate problem.

A number of pharmaceutical makers, including Johnson & Johnson, Pfizer and several biotech companies, are testing new drugs to treat the sexual complaint of premature ejaculation. The condition affects 15% to 30% of American men, according to many estimates. That makes it more common than erectile dysfunction, which affects about 10% of men. In the wake of the success of impotence drugs like Viagra, which are now a $2.5 billion-a-year industry world-wide, drug companies hope the emerging treatments could represent the next generation of blockbuster lifestyle drugs.

One of the new drugs, Johnson & Johnson's dapoxetine, has been under review by the Food and Drug Administration for six months and soon could be the first treatment approved for the condition. A major study presented yesterday at the American Urological Association annual meeting in San Antonio showed dapoxetine pills could help men with the dysfunction delay orgasm. Before taking the drug, the men in the study ejaculated less than a minute after starting intercourse, on average; the drug helped them last about two to three minutes longer. The study, which also showed the drug has some unpleasant side effects including nausea, has been submitted to the FDA as part of the final stage of the drug-approval process, known as Phase III. Even before a drug is approved specifically for the condition, some doctors are quietly prescribing a number of existing drugs. The most common are a class of antidepressants that includes Paxil and Zoloft and has been shown to delay orgasm. Other approaches include prescription topical numbing agents such as lidocaine and a range of unproven over-the-counter products, such as the herb damiana.

Researchers are also exploring whether erectile-dysfunction drugs like Viagra can alleviate premature ejaculation.

The move to treat the disorder with drugs is sparking debate about whether drugs are always necessary. A number of past studies have shown that nondrug interventions, such as therapy and behavioral changes, can be 70% to 80% effective. Even the new study on dapoxetine found that men taking a placebo were also able to increase their staying power.

Some critics worry that the drug industry may try to cast a range of normal sexual behavior as problematic in an effort to create a market for the new drugs.

But like impotence, premature ejaculation is recognized as a legitimate medical diagnosis, and is listed in the official manual of mental disorders used by the psychiatric community. As with other conditions that were once though to be purely psychological, such as depression, research increasingly suggests the condition has a biological basis.

The idea of treating it with a pill emerged only recently. Some see it as just the latest step in the drug industry's growing push to target lifestyle issues.

MEN'S HEALTH

Prevalence of male sexual problems:

•Climax too early: 30.7%

•Anxious about performance: 17.8%

•Lacked interest in sex: 14.7%

•Trouble maintaining or achieving erection: 10.2%

•Sex not pleasurable: 8.3%

•Unable to achieve orgasm: 7.8%

Source: Journal of the American Medical Association, based on survey of
1,410 men, age 18 to 59

There is some speculation about whether the drugs could delay orgasm in men with normal sexual function -- potentially creating an even larger lifestyle market. Jon Pryor, chairman of the University of Minnesota urology department and the principal investigator on the dapoxetine study, says he believes the drug could potentially delay ejaculation in the general male population, though a potential downside could be an inability to achieve orgasm at all. Johnson & Johnson says it is testing the drug strictly on men diagnosed with premature ejaculation and will market it only to that group if it is approved.

Drug makers face some challenges if they want these new drugs to rival the likes of Pfizer's Viagra, which passed the $1 billion sales mark within a year. A report by Merrill Lynch on Johnson & Johnson's drug pipeline estimated that U.S. sales of dapoxetine in 2008 could range from $350 million to $1.15 billion.

Dapoxetine didn't significantly improve the sex lives of everyone who tried it in the study. Less than 50% of the dapoxetine study participants reported "good" or "very good" satisfaction with sex at the end of the study.

One challenge for drug companies, doctors and patients is defining what constitutes "premature." A recent study in the Journal of Sexual Medicine sponsored in part by Johnson & Johnson attempted to define the problem by giving stopwatches to the wives and girlfriends of 1,587 men, and asking them to measure the period between penetration and ejaculation. Men who considered themselves "normal" averaged 7.3 minutes. Men who considered themselves "premature" averaged 1.8 minutes. But the study also found that anxiety over the issue varied greatly.

"The number of men who want to be treated for PE is far less than the men who report having it," says Ira Sharlip, a urologist and spokesman for the American Urological Association.

Johnson & Johnson is confident there will be a market for the drug. "There's a lot of cynicism out there about if this really is a condition or not," says Usman Azam, the company's vice president of urology drug research and development. But he notes that 10 years ago, people thought the same way about impotence.

Dapoxetine works in a similar manner to SSRI (selective serotonin reuptake inhibitors) antidepressants like Paxil, which regulate levels of the neurotransmitter serotonin in the brain -- but it works much faster and can be taken one to three hours before sex. Ongoing research suggests that changes in serotonin metabolism in the central nervous system may be responsible for the timing of ejaculation. Ironically, SSRI antidepressants are known to have sexual side effects such as damping libido. But the sexual side effects may be less-pronounced in a short-acting pill.

Pfizer is also testing a short-acting SSRI to treat premature ejaculation. The experimental drug had progressed to the early clinical trial stage in 2003, according to a review of research projects the company released that year. A Pfizer spokesman declined to give an update on the project but said the company "is conducting studies." Several smaller companies are also working on pills, including Enhance Biotech of North Carolina.

Some doctors have also been studying whether impotence drugs could help men with premature ejaculation. The results are mixed. While one study suggested sildenafil citrate, the active ingredient in Viagra, can delay ejaculation, a more recent study found the drug did not. (Even with Viagra, men lose their erection after ejaculation.) The new Johnson & Johnson-funded study on dapoxetine involved 2,614 men age 18-77 in stable, heterosexual relationships. All were diagnosed with premature ejaculation. (That meant they typically ejaculated in under two minutes after sex started and felt considerable distress over the issue.) One group took a 30-milligram dose of the drug, another group took a 60-milligram dose, and a third group took a placebo. Wives and girlfriends timed intercourse with a stopwatch over a 12-week period.

Men taking the highest dose of the drug were able to last for just over three minutes, up from an average of 55 seconds. But they also had the highest rate of side effects: About one in five experienced nausea and 6%-7% experienced headache, diarrhea or dizziness. Side effects were milder at the 30-milligram dose. On that dose, men were able to delay ejaculation to about 2.8 minutes. Men in the placebo group were able to delay ejaculation slightly -- to about 1.8 minutes.