Dapoxetine

Dapoxetine is the International Nonproprietary Name of a short-acting SSRI drug currently being considered for approval by the 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. This would make it join the ranks of sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®), the erectile dysfunction drugs and cabergoline (Dostinex®) (off-label), as a drug invented to improve male sexual health.

Dapoxetine, submitted to the FDA in the form of dapoxetine hydrochloride, was developed by ALZA Corporation and its parent company, Johnson & Johnson.

Like other drugs specifically targeted to treat premature ejaculation, it is controversial for turning something that is traditionally considered psychological into a physiological problem that can be treated, to the benefit of the pharmaceutical industry (but also to the people with the dysfunction).

In October of 2005, the Food and Drug Administration issued a nonapprovable letter for Dapoxetine

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