Finland gives licence for premature ejaculation drug rejected by FDA

US officials turned down licence application in 2005

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Finland is among the first countries in the world to allow doctors to prescribe dapoxetine, a drug developed to treat men with premature ejaculation.
      Earlier in the month Sweden also approved the use of dapoxetine, and a number of other European countries are considering the move.
     
Professor Hannu Koistinen, of the Departument of Urology of the Helsinki University Central Hospital, notes that the problem of men reaching orgasm too fast has long been something of a taboo.
      It has generally been seen that a man suffers from premature ejaculation if intercourse regularly lasts for less than two minutes.
      “That is just a limit set in research. It is a very subjective matter how a person experiences it."
      The disorder is often seen to be psychological, although studies suggest that this is not the case, he says. Some men are so distressed by the situation that they actually start avoiding sexual contact.
     
The US Food and Drug Administration turned down a licence application for sale of dapoxetine in 2005. The manufacturer is considering a possible new application.
      “We knew this, but in Europe, decisions are made based on our own consideration”, says Pekka Kurki, head of the sales licence section of the Finnish National Agency for Medicines.
      Denying a licence the first time around is not rare, says Juhana J. Idänpään-Heikkilä, medical director of Janssen-Cilag, which markets dapoxetine.
     
There has been discussion in the United States over whether or not premature ejaculation is a disease which requires a pharmaceutical treatment. In a few rare cases, test subjects taking the drug fainted unexpectedly.
      “It is always possible to ask where to draw the line on what is a disease and what is not”, Koistinen says.
      His patients took part in clinical tests of dapoxetine, and he has no financial ties with the company that sells the drug.
      Dapoxetine is taken 1-3 hours before intercourse, and studies indicate that it increases the duration of lovemaking by a few minutes.


Links:
  Dapoxetine - Wikipedia

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