J&J Ejaculation Pill, World’s First, Wins Approvals (Update2)
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By Alex Nussbaum

Feb. 10 (Bloomberg) -- Johnson & Johnson won approval in Sweden and Finland for the first prescription pill to treat premature ejaculation, three years after U.S. regulators rejected the drug, the company said.

The drugmaker expects to win clearance for dapoxetine, to be sold as Priligy, in five more European nations and has applied for approval in Canada, Australia, Mexico, Turkey and six other countries, said Greg Panico, a spokesman for New Brunswick, New Jersey-based J&J, today in a telephone interview. The pill, taken a few hours before intercourse, should be in European drugstores by April, he said.

“There’s a globally significant market” for premature ejaculation treatments, Panico said. He declined to estimate sales.

Dapoxetine may generate $575 million a year by 2011 for the company, said Michael Weinstein, a JPMorgan Chase & Co. analyst in New York, in an Oct. 29 note to clients. It’s one of several drugs J&J is developing to replace revenue it expects to lose to generic competition to top-selling medications such as the antipsychotic Risperdal, he said.

Johnson & Johnson fell $1.77, or 3 percent, to $56.73 in New York Stock Exchange composite trading at 4 p.m.. The company has lost 8.5 percent over 12 months.

Potential Patients

From 4 percent to 30 percent of men worldwide suffer premature ejaculation at some point in their lives, Panico said. Estimates vary because some men are embarrassed to admit the condition, he said. J&J defined the condition as ejaculation within a minute of penetration. The Merck Manual of Medical Information defines it as ejaculation sooner than men or their partners would like.

The U.S. Food and Drug Administration turned down J&J’s application to sell dapoxetine in 2006 without explanation. Panico wouldn’t discuss the FDA rejection. He said J&J was “keeping its options open” to resubmit the pill in the U.S.

Dapoxetine neutralizes a chemical messenger in the brain called serotonin, the neurotransmitter also affected by antidepressants such as Eli Lilly & Co.’s Prozac. The antidepressants also may be prescribed to treat premature ejaculation, according to the National Institutes of Health.

The serotonin-targeting drugs have been subject of thousands of lawsuits against companies including Pfizer Inc., GlaxoSmithKline Plc. and Merck & Co. by patients who say the medicines increased the risk of suicide.

Five clinical trials involving 6,000 men using dapoxetine found no evidence suicide or suicidal thoughts increased, Panico said. J&J’s drug is taken as needed, so it should pose fewer potential dangers than antidepressants taken regularly, he said.

The drug was originally developed by Lilly as a potential antidepressant and licensed to J&J, Panico said. The company is also awaiting decisions on approval in Austria, Germany, Spain, Italy and Portugal, said a statement morning by Janssen-Cilag EMEA, the J&J unit marketing the drug.

To contact the reporter on this story: Alex Nussbaum in New York anussbaum1@bloomberg.net.

Last Updated: February 10, 2009 16:17 EST

Does the pill make you think about sports your mom just getting out of the shower?

If you can maintain an erection whilst thinking about your mom in any capacity, more power to you. I cannot.

im pretty sure youve already got the come in handy thing down pat

that guys email is annusbaumm

that guys email is annusbaumm

i bet it gives you blood clots in your penis

already got 'em!