Dapoxetine is the first oral drug to receive regulatory approval for treating men suffering from Premature Ejaculation. Dapoxetine, which is sold as Priligy, has been approved for sale in Finland and Sweden with several other European countries expected to follow shortly.
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Dapoxetine (brand name Priligy) belongs to a class of drugs called SSRI's, which is short for selective serotonin re-uptake inhibitor. This class of medications is typically associated with anti depressants, usually used to treat anxiety, depression and personality disorders. However tests have shown that premature ejaculation may be linked to men with low serotonin levels and anti-depressants have been prescribed 'off-label' for many years to help men suffering from PE. Dapoxetine has been so successful in trials as it is a short-acting SSRI, meaning that only a trace of the medication is left in the body after a few hours. This removes the majority of side effects typically associated with SSRI's and anti-depressant drugs. It is designed to be taken orally and only as required, 1-3 hours before sexual activity.
Dapoxetine may soon join the ranks of other successful drugs such as Viagra, Cialis and Levitra as drugs that can improve the quality of male sexual health. Whilst the other 3 are specifically impotence treatments, Dapoxetine is the first oral medication ever approved for treating Premature Ejaculation. Trials have shown that Dapoxetine increases the duration of sex for men suffering from PE by an average of 200-300%.
Dapoxetine has received first regulatory approval to be sold in Finland and Sweden, with several other European countries expected to receive approval shortly. The drug is expected to be available in pharmacies in the approved countries from April 2009. In Europe, the drug will be marketed under the name Priligy. Dapoxetine has not yet received approval to be marketed in the United States and there has not been a specific date set on its arrival to the UK market. The pharmaceutical company Janssen-Cilag currently owns all rights to Dapoxetine and where it is made available; a prescription from a healthcare professional will be required.
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Dapoxetine has been tested extensively in Phase III trials involving over 6,000 men suffering from premature ejaculation and their partners. To date, this is the largest trial ever conducted into drug therapy for PE. The drug was tested in men aged between 18-77 years old who maintained sexual relations with their partner for more than six months. For 12 weeks, patients were given 60mg, 30mg or a placebo dummy pill. Dapoxetine was found to have an effect on ejaculation, with the length of sexual intercourse trebling in many cases. The study also found that Dapoxetine was well tolerated, with most side effects being mild-to-moderate in their severity. The most common side effects reported were headaches and nausea, all of which passed within a few hours after taking the treatment.
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