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J&J unveils sexual dysfunction data
J&J says drug extends intercourse, reduces premature ejaculation, analyst calls it an 'utter joke.'
May 23, 2005: 1:08 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - Johnson & Johnson unveiled data for a potential treatment for male sexual dysfunction, though an analyst downplayed the effectiveness of the drug.

The drug-making giant announced on Monday that dapoxetine hydrochloride, a treatment for premature ejaculation, showed promising results in late-stage testing. The Food and Drug Administration has yet to approve the drug.

Johnson & Johnson (up $0.13 to $67.33, Research) conducted phase III clinical trials on more than 2,600 men aged 18 to 77 who suffered from premature ejaculation and were in monogamous relationships. Participants timed their results using stop watches, and those taking dapoxetine reported a three to four-fold increase in their performance time.

However, an analyst who covers the company but did not want to be named said that dapoxetine is an antidepressant with a side effect causing erectile dysfunction. The analyst accused Johnson & Johnson of turning the side effect into a cure for premature ejaculation.

"The fact that they are selling this as a cure for premature ejaculation is an utter joke," said the analyst. "One of the problems it's causing is that some people can't reach orgasm. So they're turning the side effect into a drug."

Dr. Usman Azram, vice president of Johnson & Johnson's research and development department for urology, said he was "disappointed" with the analyst's comments. Azram defended dapoxetine as a targeted product, not a side effect, that was specifically tailored to address premature ejaculation. He said the drug was not being tested as an antidepressant.

"From a research and development standpoint I see this as an incredibly important compound in alleviating the suffering of millions of people worldwide," said Azram. "We really feel that we're on the edge of addressing an unmet medical need for men around the world. There are no approved treatments in the U.S. or anywhere in the world for premature ejaculation."

The patent for dapoxetine was originally held by Eli Lilly & Co. and was bought by PPD, Inc. in 2003. PPD then licensed the drug to ALZA Corp., a subsidiary of Johnson & Johnson.

Bear Stearns analysts project that if dapoxetine enters the market in early 2006, it will total $160 million in sales that year and will hit $500 million in sales in 2007, according to a report released on May 20.

Johnson & Johnson submitted the drug to the Food and Drug Administration last year and announced test results at the 100th annual meeting of the American Urological Association in San Antonio, Texas.

Premature ejaculation is among the most common types of male sexual disorders, affecting 27 to 34 percent of all men, according to estimates from the American Urological Association.  Top of page

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