The first drug formulated to treat premature ejaculation delayed climax and increased reported satisfaction in a late-stage study, its developer, Johnson & Johnson, said on Monday.
A Phase III clinical trial of 2,614 men showed the drug provided “significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time,” Ortho-McNeil Pharmaceutical, a unit of J&J, said in a statement.
The drug, called dapoxetine, is being co-developed by J&J’s Alza Corp. and Johnson & Johnson Pharmaceutical Services, LLC units. The company’s Ortho-McNeil Pharmaceutical unit will market the drug in the United States if it receives U.S. Food and Drug Administration approval.
The American Urological Association estimates that premature ejaculation affects anywhere between 27 percent and 34 percent of men across all age ranges. Erectile dysfunction, the condition that made Pfizer’s impotence drug Viagra into a blockbuster, affects an estimated 10 percent to 12 percent 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 for PE,” said Dr. Jon Pryor, chairman and program director of the Department of Urologic Surgery at the University of Minnesota, who led the study.
Researchers working on the drug reported last month that they could define premature ejaculation. They said a man with the condition took 1.8 minutes to ejaculate after beginning intercourse compared to 7.3 minutes for most men.
They call this Intravaginal Ejaculatory Latency Time and is timed by giving the man or his sexual partner a stopwatch.
In a study presented to a meeting of the American Urological Association in San Antonio, Texas, researchers said men who took dapoxetine at doses of either 30 mg or 60 mg had a three- to four-fold increase in this time compared to men given a placebo.
The percentage of men rating control over ejaculation as “fair to very good” increased from 2.5 percent before getting the drug, to 51.8 percent afterwards for men who got the lower dose, to 58 percent of men given the higher dose.
Of the men who got the placebo, 3.5 percent reported fair to very good control before getting the dummy pill and 26.4 percent said so afterwards.
“The percentage of men rating sexual satisfaction as ’good to very good’ almost doubled with dapoxetine 30 mg (20.2 percent to 38.7 percent) and 60 mg (22.3 percent to 46.5 percent),” the company said. Just under 25 percent of men who got the placebo reported good sexual satisfaction.