24 May, 2005 01:23 GMT
Men taking the drug experienced better results compared with placebo for time, control, satisfaction and partner satisfaction.
Men taking Johnson & Johnson's premature ejaculation treatment, dapoxetine hydrochloride, experienced improvements in sexual function, including control and satisfaction, a J&J unit said Monday.
The unit, Ortho-McNeil Pharmaceutical Inc., said the Food and Drug Administration is currently reviewing a new drug application for dapoxetine.
If approved, the company said, the drug would be the first prescription product indicated for the treatment of premature ejaculation.
Shares of J&J, the drugmaker based in New Brunswick, N.J., rose 6 cents to close at $67.26 on the New York Stock Exchange.
The phase III clinical trial for dapoxetine, which is being developed by Ortho-McNeil's Ortho Urology unit, involved 2,614 men in monogamous sexual relationships of greater than six months. Men in the studies received either 30 milligrams or 60 mg of dapoxetine over 12 weeks in two identical trials.
The company noted men taking the drug experienced better results compared with placebo for time, control, satisfaction and partner satisfaction.
Data from the study was presented at the annual meeting of the American Urological Association.
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