Yesterday I published an item that indicated J&J had no luck with dapoxetine, the drug it was developing to cure premature ejaculation. I had been under the impression J&J was still working on it but the FDA canned it in October 2005. There has been some buzz that such a drug could be the new Viagra (or anti-Viagra, if you like). I also heard from a source who indicated that J&J had closed up its dapoxetine operations here in the U.S.
But it turns out that J&J is still pouring money into dapoxetine. This blog says that was the case back in April 06 and a note today from analysts FBR indicates that Pharmaceutical Product Development Inc. is still working on the drug and is expecting milestone payments from J&J:
The company "noted that Johnson & Johnson expects to file dapoxetine for approval in Europe in 2007 and will host an R&D day on June 7, 2007, with new dapoxetine data. Eshelman also noted that Glaxo's Avandia is a different class of drug from Takeda's DPP4 inhibitor and reminded investors of Takeda's industry-leading diabetes franchise in support of the late-stage Phase III trials for the DPP4 inhibitor compound," per FBR.
Indeed, David Norton,J&J's chairman/worldwide commercial operations told the Citigroup Healthcare Conference on May 23 that "Dapoxetine, we intend to file in Europe by the end of year."
So perhaps dapoxetine was a bit, er, longer lasting than I thought ...

I am interested in the science of male and sexual function and has been following the up and down story of dapoxetine. The drug's data in various FDA clinical trials were reasonable in terms of efficacy and safety. The hold up is the FDA concern about any drug in the SSRI category and how good and how safe a drug needs to be for a life style condition.
Be interesting to see what the EU regulatory think in 08 if J+J files by end of 07.
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Indeed, David Norton,J&J's chairman/worldwide commercial operations told the Citigroup Healthcare Conference on May 23 that "Dapoxetine, we intend to file in Europe by the end of year.
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