Dapoxetine

Overview
Dapoxetine is the International Nonproprietary Name of a short-acting SSRI drug currently being considered for approval by the Food and Drug Administration (FDA) for the treatment of premature ejaculation in men, which would make it the first drug approved for such treatment. It is currently in Phase III of the approval process.

Function
If approved, this would make Dapoxetine join 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 which 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.

Some research has shown Dapoxetine to have a benefit in the treatment of premature ejaculation.

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 of 2005, the FDA issued a "not approvable" letter for dapoxetine.

Despite two clinical trials finished in 2006, experts doubt it will be approved by the FDA soon because SSRIs come with undesirable side-effects after long-term use, such as psychiatric problems, dermatological reactions, increase in body weight, lower sex-drive, nausea, headache, upset stomach and weakness, thus not significantly outweighing the benefit of premature ejaculation medication versus the risks.