J&J still seeking approval of sexual dysfunction pill

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Johnson & Johnson hasn't given up on becoming first to market with an Rx drug approved for premature ejaculation, The Wall Street Journal reports.

The drugmaker is readying to file for approval of its selective serotonin uptake inhibitor (SSRI) dapoxetine as a premature ejaculation treatment in Europe and in Canada later this year and has yet to rule out another bid at US FDA approval of the drug.

Federal regulators rejected dapoxetine for premature ejaculation in 2005. Since then, J&J has completed additional patient studies that have demonstrated dapoxetine’s safety and effectiveness, the drugmaker said.

Doctors say demand for such a drug would be strong since about 20% to 30% of men lack control over ejaculation and reach climax sooner than they would like.

Currently, the condition is treated with other SSRI’s, including GlaxoSmithKline's Paxil and Pfizer's Zoloft, although these drugs are prescribed off-label by physicians for this use.

If J&J is successful, dapoxetine could generate global sales of $600 million by 2011, according to Morgan Stanley, assuming the drug goes on sale in ex-US markets in 2008 and in the US in 2009.

Analysts predict that dapoxetine will be priced around the same as Pfizer’s anti-impotence treatment Viagra, which sells for more than $10 per pill at drugstore.com.

J&J licensed dapoxetine from global contract research organization Pharmaceutical Product Development, which previously licensed the compound from Eli Lilly. Both companies would stand to collect royalties from any sales of dapoxetine.

The drug could prove tricky to market even though the trail for sexual dysfunction treatments was blazed by Viagra nearly a decade ago, The Journal reports.
Mark Bard, president of market research firm Manhattan Research, said that conveying dapoxetine’s condition and treatment in a medium such as a 30-second TV spot might prove difficult.

An additional marketing obstacle may be illustrated by the statistic from a 2005 Decision Resources survey that states most men preferred to receive information about treatments from their doctors, with TV ads, “low on the scale,” said Decision Resources analyst Dancella Fernandes.

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