AUA 2009: Investigational Agent Significantly Prolongs Latency in Premature Ejaculation

Martha Kerr

April 29, 2009

April 29, 2009 (Chicago, Illinois) — Phase 3 results from a European study of PSD502, a topical spray for the treatment of premature ejaculation, has shown strongly positive results, achieving a more than 6-fold increase in the latency period with virtually no adverse effects. The results were presented here at the American Urological Association (AUA) 104th Annual Scientific Meeting.

PSD502 is a nonionized combination of lidocaine 7.5 mg and prilocaine 2.5 mg in a eutectic-like propellant that is sprayed on the glans penis 5 minutes before sexual intercourse.

"Because it is nonionic, it penetrates the surface of the penis, unlike other topical anesthetics," principal investigator W. Wallace Dinsmore, MD, from Royal Victoria Hospital in Belfast, Ireland, told Medscape Urology just before presenting the study findings.

The onset of action is 5 minutes. In this study of 300 men with premature ejaculation, latency time increased from 0.6 minutes at baseline to 3.8 minutes with treatment (P < .0001). "A normal latency time is about 4.6 minutes," he said, "so this moves them into the near-normal range."

"There have really been no safety concerns," Dr. Dinsmore said. There were 5 men who experienced mild adverse effects. There was 1 case of hypoesthesia, 2 cases of erythema, 1 case of burning, and 2 cases of loss of erection.

"There is very little hypoesthesia because the anesthetic penetrates the skin and doesn't stay on the surface."

"Nearly all of these patients have volunteered for the long-term safety follow-up study because they were so happy with the results. We even had some patients who tried to steal the drug after the study was over because they didn't want to stop it."

"What's really impressive here is that we are treating 2 individuals, the patient and the partner," Ira Sharlip, MD, clinical professor of urology at the University of California at San Francisco, and spokesperson for the AUA, told Medscape Urology. "A lot of men don't care if they have premature ejaculation, but their partners do. The influence of the partner is very important. Patient and partner satisfaction was very high in this study."

Dr. Sharlip continued: "There is no [US Food and Drug Administration]–approved treatment for sexual dysfunction. [Selective serotonin reuptake inhibitors] are often prescribed, but there are adverse effects and the onset of action is very long [and indirect]."

"Oral agents inhibit spontaneity. PSD502 has a very short onset of action and does not inhibit spontaneity. I've never seen anything like this drug." Dr. Sharlip said.

Dr. Dinsmore's study was funded by Sciele Pharma in Europe and Plethora Solutions (Timm Medical Technologies, Inc.) in the United States. Dr. Sharlip has disclosed no relevant financial relationships.

American Urological Association 104th Annual Scientific Meeting: Abstract 1370: Presented April 28, 2009.