Dapoxetine

Dapoxetine (INN, brand name Priligy) is a short-acting selective serotonin reuptake inhibitor (SSRI) marketed for the treatment of premature ejaculation in men. Dapoxetine is the only drug with regulatory approval for such an indication. Currently, it is approved in several European countries, including Finland, Sweden, Portugal, Austria, Italy and Germany. Dapoxetine is also being considered for approval in other European countries and in the United States, where it is currently in Phase III of the U.S. Food and Drug Administration (FDA) approval process.

Function
Several studies have suggested that dapoxetine has 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 trial, authors conclude that dapoxetine is well-tolerated and improved measures associated with premature ejaculation, including reduction of personal distress, interpersonal difficulty and improvement in the satisfaction with the sexual intercourse.

History
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 and future royalties in December 2003. In 2004, 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). However, the FDA issued a "not approvable" letter for dapoxetine, requiring additional clinical study. Two further clinical trials were completed in 2006, and approval is under review by the FDA.

Dapoxetine has been submitted for approval in the European Union and is being reviewed. In 2009, dapoxetine received approval in Sweden, Finland, Spain, Portugal, Germany, Austria, Italy, and New Zealand. Approvals for dapoxetine are also anticipated in other European countries as well. In addition, filings for approval have been submitted in Canada, Australia, Mexico, Turkey, and six other countries.