New Drug Spray May Help Premature Ejaculation
Study Shows Some Improvement for Men Who Use Spray Before Sex
Testing the New Drug continued...
In the PSD502 group, scores on a 20-point ejaculatory control scale increased from an average of 4.9 points at the start of the study to 13 points three months later. In the placebo group, scores increased from 4.8 to 7 points.
On a 20-point satisfaction scale, both groups rated themselves an average of 6.9 points at the start of the study. By three months, the scores were 8.9 points in the placebo group and 14.2 points in the PSD502 group.
"We saw progressive improvement with PSD5092. That doesn't necessarily mean it's all the drug; there could be psychoeducational effects as men became more confident," says Sharlip. That also may help explain why men in the placebo group saw some improvement, he says.
A total of 6.1% of the men and 6.7% of their partners suffered at least one side effect.
In men, the most frequent side effect was loss of erection; it occurred at least once in 3.1% of men. In the partners, the most frequent side effect was burning in the vulvovaginal area; 5% of women reported it at least once.
"None of the side effects were serious, which is very important as this is a quality-of-life condition," not a life-threatening disorder, Sharlip says.
Another study presented at the meeting showed PSD502 appears to work for both circumcised and uncircumcised men with premature ejaculation, but uncircumcised men gain more benefit. That's probably because there's more surface to spray, the researchers hypothesize.
Researchers still don't know exactly how PSD502 works, but "it could be that altering input from the penis to the brain ultimately limits excitation," Goldstein says.
The drug is so new that the company has yet to give it a name under which it will be marketed. Donald Manning, MD, PhD, chief medical officer of Shionogi, says the company is preparing to apply for FDA approval based on the results of the new research. No price has been set.
This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.