Dapoxetine is the only licensed drug in the treatment of PE. It has been approved for treatment for the treatment of PE in New Zealand, Sweden, Austria, Finland, Germany, Spain, Italy and Portugal. National approvals and licenses in five other European countries are expected to follow. Dapoxetine is not approved for marketing in the United States.
Dapoxetine is a drug specifically developed for the on-demand treatment of PE. It has been extensively evaluated in five randomized, placebo- controlled phase III clinical trials involving more than 6000 men with PE. This is the largest and most comprehensive clinical trial programme to date for a drug therapy to treat PE. It is a short-acting SSRI designed to be taken only when needed and is taken 1–3 hours before sexual intercourse is anticipated.
There is evidence of its efficacy, its relatively mundane الدنيوية side effect profile and its validity as an on-demand medication [Feige et al. 2011; Hoy and Scott, 2010; Kaufman et al. 2009; McMahon et al. 2009; Giuliano et al.2007]. However, the durability of the effects of dapoxetine has not yet been demonstrated in prospective, randomized trials since long-term follow up is not yet available [Safarinejad and Hosseini, 2006].