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Overall10of the men continued taking dapoxetine for the entire two yearsDiscontinuation rates increased over timeJust over a quarter of the men stopped therapy during the first monthIn 6 months79had stopped taking dapoxetineand by 24 monthsthe rate was 90

Although SSRIs are intended for chronic use in the treatment of depression and are designed to have pharmacokinetic profiles that would allow them to provide constant systemic concentration with long-term administrationthey may need days to weeks to reach a maximum steady-state concentration in order to exhibit efficacyHiemke and Hartter 2000ThereforeSSRIs are commonly used in a daily dosing schedule for the treatment of PEMontague et al 2004In addition to the potentially desirable side-effect of delaying ejaculationthis dosing regimen for long-acting SSRIs is associated with a number of undesirable side-effectssuch as decreased libido and EDMontague et al 2004With the success of daily SSRI use in delaying ejaculationit has been suggested that on-demand treatment with SSRIs possessing a short half-life and short T max would be equally effectivemore convenientand exhibit fewer serotonergic side-effects than observed with daily treatmentWaldinger 2005Thereforean ideal compound for the treatment of PE should exhibit pharmacokinetic profiles having rapid absorptionadequate availability to establish therapeutic exposure at the target siteand rapid elimination to reduce total drug exposure and minimize the incidence of side-effectsModi et al 2006

Food does not have a clinically significant effect on dapoxetine pharmacokineticsMean maximal plasma concentrations of dapoxetine decrease slightly after a high-fat mealfrom 443 ng/mlfastedto 398 ng/mlfedand are delayed by approximately 0.5 h following a high-fat meal1.30 h fasted1.83 h fedDresser et al2006bThe rate of absorption is modestly decreasedbut there is no effect of food on the elimination of dapoxetine or the exposure to dapoxetineas assessed by the plasma concentration versu s time AUCThe frequency of nausea is decreased after a high-fat meal247/29of fasted subjects and 144/29of fed subjects respectively

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