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DAPOXETINE HCL
Dapoxetine (INN, brand name Priligy) is a short-acting selective serotonin reuptake inhibitor (SSRI) marketed for the treatment of premature ejaculation in men.[1] Dapoxetine is currently in Phase III (human trials) of the U.S. Food and Drug Administration (FDA) approval process.[2] Dapoxetine is the only approved clinical treatment chemical for premature ejaculation, ever, in men, in the world. SSRIs have long been known to cause prolonged ejaculation in men and orgasmic difficulty in women; however, the longer duration of most SSRIs means they would not be suitable for treatment of a single issue like PE when the other effects would likely outlast the benefits of treating PE. Studies have suggested that dapoxetine has strong potential in the treatment of premature ejaculation.[3] In a review of data gathered from the phase III trial, authors conclude from data that dapoxetine is well-tolerated. Secondary effects of premature ejaculation such as personal distress, interpersonal difficulty in relationships, and low satisfaction with sexual intercourse were also improved.
In 2004, dapoxetine was submitted to the FDA by the ALZA Corporation (owned by parent company Johnson & Johnson) for the treatment of premature ejaculation. The FDA issued a "not approvable" letter for dapoxetine, meaning they required additional clinical examination submitted in the form of a peer-reviewed study.[4] Two more trials were completed in 2006 and the drug is still under FDA reviewing process as of 2010.