For guys with a short sexual fuse, a new spray may help delay the grand finale
But if a new drug passes regulatory muster, guys with a short sexual fuse may be able to last a bit longer. Sciele Pharma says results of a late-stage clinical trial show that men who used its topical spray PSD502 were able to delay ejaculation five times longer than those who used a placebo, or dummy treatment. "If the results hold up with further clinical experience, I think it will have a great future in the treatment of premature ejaculation," says Ira Sharlip, a spokesman for the American Urological Association.
Atlanta-based Sciele says it plans to file a New Drug Application for PSD502 with the U.S. Food and Drug Administration next year. If all goes well, what Sciele is calling the first prescription treatment for premature ejaculation could be on the market in early 2011, says Sciele spokesman Joseph Schepers. "The fact that it is a simple aerosol spray will make it very easy to use the product," Schepers says.
Experts say the market for the drug could be big as premature ejaculation affects more men than erectile dysfunction (about 1 in 10 men have trouble maintaining an erection). In 2007, sales of ED drugs including Pfizer's (PFE) Viagra and Eli Lilly's (LLY) Cialis totaled $2.2 billion, according to industry research firm Decision Resources. "We haven't provided any specific numbers" for the potential market for PSD502, says Schepers. But he says, given that premature ejaculation affects more men than ED, "the market is very significant."
PSD502 works like this: The compound -- a proprietary formulation of lidocaine and prilocaine -- is sprayed on the head or "glans" of the penis typically five minutes before intercourse. The solution is immediately absorbed, leaving no residue, but the ability to hold out for more time. "You don't have this lack of control," says Schepers. "It prevents hypersensitivity that you might have."
Even though lidocaine and prilocaine are anesthetics commonly used in dentistry, Sciele says men -- and their partners -- are satisfied with the results. "You still have the same sensation, same feeling," says Schepers.
The recent clinical study included 256 men in the United States, Canada and Poland who during intercourse had a latency time of 36 seconds before ejaculation on average. When they used PSD502, that time extended to close to 3 minutes to 4 minutes, says Schepers. "That makes a significant difference," he says. Trial subjects who were given a placebo saw their latency time grow to just 48 seconds, Sciele says. Premature ejaculation is currently defined as ejaculation that occurs within one minute of penetration.
According to Sciele, PSD502 is safe and less than 10% of patients in the recent trial reported side effects. They were characterized as "minor sensitivity" in the genital area. Says Sharlip, "there are very few side effects and they are all local."
That hasn't been the case with existing treatments, says Sharlip, who is a clinical professor of urology at the University of California, San Francisco. There are drugs -- Selective serotonin reuptake inhibitor (SSRI) antidepressants -- that work "reasonably well," but the side effects are significant, he says. One commonly used SSRI, Paroxetine, can cause nausea, drowsiness and constipation, among other side effects. What's more, it must be taken three hours in advance of sex. "That is highly inconvenient and it has to be taken daily," Sharlip says.
Other treatments include topical cream that dull the penile skin, says Sharlip. But they must be applied 20 to 30 minutes before use and then washed off before sex -- or the man has to use a condom -- as the active ingredient can be transferred to the sexual partner. "The alternatives all have limitations," says Sharlip.
Sharlip says an effective and safe prescription treatment for premature ejaculation would be well received. Although not all men who have the condition are bothered by it, many find it very distressing, says Sharlip. "It can be source of psychological problems in terms of anxiety and depression and in starting and maintaining relationships," says Sharlip. "Some men aren't going to start relationships because they are afraid they can't have a successful sexual relationship."
Sciele, a unit of Japan's Shinogi, hasn't revealed a name yet for PSD502. But if it indeed does what Sciele says it does, you can bet men with the condition won't have any trouble finding it.