New Spray Could Treat Premature Ejaculation
Men who experience premature ejaculation could someday use a spray medication to treat this condition. Results of two studies presented at the 2010 American Urological Association Annual Meeting show that the investigational spray drug PSD502 significantly improves the time to ejaculation when compared with placebo.
The number of men who experience premature ejaculation is not clear, with some estimates ranging from 30 to 70 percent, and the Mayo Clinic stating that about one-third of men may be affected at some time during their life. Results of the National Health and Social Life Survey found that 21 percent of men ages 18 to 59 experience premature ejaculation.
One reason for the lack of accurate data is that a widely accepted definition of premature ejaculation has only recently been determined, and another is that many men do not report this problem to their doctors. The definition established by the International Society for Sexual Medicine is “A male sexual dysfunction characterized by ejaculation which is always or nearly always occurs prior to or within 1 minute of vaginal penetration; and an inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.”
According to data from the two studies, men who had premature ejaculation were selected from 70 centers in the United States, Canada, and Europe. Over a three-month period, two-thirds of the participants used PSD502 and one-third were given a placebo to use. The spray was applied five minutes before intercourse via a metered dose.
Men who used PSD502 were able to maintain an erection 5.5 times longer than men who used the placebo spray. Men who used PSD502 also reported better ejaculatory control and overall satisfaction. Side effects were reported by 6.1 percent of the patients who used PSD502 compared with 0.6 percent of men in the control group. Five percent of the men’s sexual partners reported vulvovaginal burning.
Currently there are no Food and Drug Administration approved medications for treatment of premature ejaculation. According to a recent report in Drug Design, Development and Therapy, behavioral therapy has been used but the results are not lasting. Several topical treatments have been used, including lignocaine spray, lidocaine-prilocaine cream, and lidocaine-prilocaine spray. An antidepressant called dapoxetine has also showed some promise.
Ira D. Sharlip, MD, clinical trial investigator and clinical professor of urology at the University of California, San Francisco, notes that “combined results from the PSD502 pivotal studies are very exciting.” PSD502 is a proprietary formulation (Shionogi Pharma Inc.) of lidocaine and prilocaine, both of which are local anesthetics. The spray medication is currently under investigation for treatment of primary premature ejaculation.
Linton KD, Wylie KR. Drug Design, Development and Therapy 2010 Feb 18; 4;1-6
McMahon CG et al. British Journal of Urology International 2008; 102(3): 338-50
Shionogi Pharma Inc.