Priligy: New druds for premature ejaculation

[wl-hunter]

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.

What is Dapoxetine?

Dapoxetine (brand name Priligy) belongs to a class of drugs called SSRI’s, which is short for selective serotonin reuptake 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%.

When will Dapoxetine (Priligy) be available?

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.

What are the side effects of Dapoxetine?

Dapoxetine has been tested extensively 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.

[wl-hunter]

Function

Research has shown dapoxetine to have a benefit in the treatment of premature ejaculation. In a report published in the 'British Journal of Urology' based on data from the phase III trail authors conclude that dapoxetine is well tolerated and found to improve all variables associated with premature ejaculation including reduction of personal distress, interpersonal difficulty and improvement in the satisfaction with the sexual intercourse.

Dapoxetine joins the ranks of erectile dysfunction drugs such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), and some dopamine agonists such as cabergoline (Dostinex) and pramipexole, as drugs that can be used to improve male sexual health. Misuse of these drugs as aphrodisiacs or sexual enhancers in individuals who do not suffer from sexual health problems is also a possibility, and there have been some concerns about doctors being pressured to prescribe such drugs off-label to people who do not actually have a medical need for the drug.

[wl-hunter]

Approval Process

Dapoxetine was created by Eli Lilly and Company and is credited to biochemist David T. Wong. Originally known as LY 210448, it was being developed by Lilly as an antidepressant. Eli Lilly sold the patent to Johnson & Johnson for $65 million dollars and future royalties in December 2003.

Dapoxetine was submitted to the FDA in the form of dapoxetine hydrochloride by the ALZA Corporation and its parent company, Johnson & Johnson, for the treatment of premature ejaculation with a New Drug Application (NDA) to the Food and Drug Administration (FDA) on December 28, 2004.

In October 2005, the FDA issued a "not approvable" letter for dapoxetine, delaying approval in the United States.

Despite two further clinical trials completed in 2006, it has yet to be approved by the FDA.

Dapoxetine was submitted for approval in Europe and is now being reviewed.

In Feb 2009, it has first received approval in Sweden & Finland. Later, in Austria, Portugal and recently in Germany. Approvals for dapoxetine are also anticipated in other European countries as well. Filings for approval have been submitted in Canada, Australia, Mexico, Turkey and six other countries.

[wl-hunter]

Spelling error. Should be new drugs. My bad. :)