CHICAGO—An investigational topical spray is safe and effective for treating premature ejaculation (PE), according to researchers in Northern Ireland.

The experimental spray, called PSD502, is an aerosol formulation of lidocaine and prilocaine that selectively desensitizes the inner lining of the foreskin and the surface of the glans penis. This improves the intravaginal ejaculatory time (IELT) without interfering with the sensation of ejaculation.

PE treatments already in use consist of topical creams with desensitizing agents that dull penile skin and delay ejaculation. Although effective, the treatments require use of a condom and/or washing away the cream before intercourse, which is not the case with PSD502.

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“This is a very significant advance in the treatment of premature ejaculation, which is a very common condition,” said principal investigator Wallace Dinsmore, MD, Professor of Sexual Medicine at the University of Ulster in Belfast. “The results were very significant, with an improvement in ejaculation time by sixfold.” He presented study findings here at the American Urological Association Annual Meeting.

Dr. Dinsmore and his colleagues evaluated PSD502 in 300 men with primary PE diagnosed according to a recently published International Society of Sexual Medicine definition (including an IELT of less than 60 seconds). The men were enrolled at clinical sites in England, the Czech Republic, Hungary, and Poland. Study participants applied PSD502 or a placebo spray five times to the glans five minutes before intercourse. 

Both groups had an average baseline IELT of 0.6 minutes. After treatment, the IELT was four minutes in the PSD502 group compared with only one minute in the placebo arm.

In addition, men treated with PSD502 reported improvements in ejaculatory control, sexual satisfaction, and distress. The spray was well-tolerated by the men and their partners, with no systemic or serious adverse events reported.

Only 2.6% of the PSD502 group reported any treatment-related adverse events, compared with 1% of the placebo group. “There were virtually nil side effects,” Dr. Dinsmore told Renal & Urology News. “Some of the men had a little local irritation, but that was it.”

Bottles of the spray will contain enough for up to 15 sexual encounters. The product could be approved for commercial use in the United States within the next 18-36 months, he said.

“Premature ejaculation is one of the most common sexual dysfunctions in men,” said AUA spokesperson Ira Sharlip, MD, who is a sexual medicine specialist.

“It occurs in 20%-30% of men of all ages, and we need an effective, patient-friendly treatment for this distressing problem. This new topical spray has promise to become one of the most effective treatments for premature ejaculation. It has a number of characteristics that will be attractive to patients with [the disorder].”

The spray should be an attractive option because it has a rapid onset and does not require men to wear a condom or wash off the product, he said.