Developer Hails Results of Ejaculation Drug Test

The first drug formulated to treat premature ejaculation delayed climax and increased reported satisfaction in a study, its developer, Johnson & Johnson, said Monday.

A late-stage clinical trial of 2,614 men showed that the drug provided “significant improvements in sexual function,” Ortho-McNeil Pharmaceutical, a unit of J&J;, said in a statement.

The drug, dapoxetine, is being co-developed by J&J;’s Alza Corp. and Johnson & Johnson Pharmaceutical Services. The company’s Ortho-McNeil Pharmaceutical unit will market the drug if it receives U.S. Food and Drug Administration approval.

The American Urological Assn. estimates that premature ejaculation affects 27% to 34% of men across all age ranges. Erectile dysfunction, the condition that made Pfizer’s drug Viagra into a blockbuster, affects an estimated 10% to 12% of men.

“The impact premature ejaculation can have on men and their partners can be devastating for a relationship, and, currently, there are no truly optimal therapies,” said Dr. Jon L. Pryor, chairman and program director of the department of urologic surgery at the University of Minnesota, who led the study.

Researchers defined premature ejaculation after giving men or their partners a stopwatch: A man with the condition took 1.8 minutes to ejaculate after beginning intercourse compared with 7.3 minutes for most men.

In a study presented to the American Urological Assn. in San Antonio, researchers said men who took dapoxetine at doses of 30 mg or 60 mg had a three- to four-fold increase in this time compared with men given a placebo.

The percentage of men rating their control as “fair to very good” increased from 2.5% before getting the drug to 51.8% afterward for men who got the lower dose, and to 58% of men given the higher dose. Of the men who got the placebo, 3.5% reported fair to very good control before getting the dummy pill and 26.4% said so afterward.