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Federal government websites often end in. The site is secure. Premature ejaculation PE is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological consequences. Pharmacotherapy of PE with off-label antidepressant selective serotonin reuptake inhibitors SSRIs is common, effective and safe. Development and regulatory approval of drugs specifically for the treatment of PE will reduce reliance on off-label treatments and serve to fill an unmet treatment need.
The objective of this article is to review evidence supporting the efficacy and safety of dapoxetine in the treatment of PE. This search was then manually cross referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase I, II and III studies, independent postmarketing and pharmacovigilance efficacy and safety studies and drug-interaction studies. Dapoxetine is a potent SSRI which is administered on demand 1—3 h prior to planned sexual contact.
It is rapidly absorbed and eliminated, resulting in minimal accumulation, and has dose-proportional pharmacokinetics which are unaffected by multiple dosing.
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Dapoxetine 30 mg and 60 mg has been evaluated in five industry-sponsored randomized, double-blind, placebo-controlled studies in men aged at least 18 years. The most common treatment-related adverse effects included nausea Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine. Over the past 20—30 years, the premature ejaculation PE treatment paradigm, previously limited to behavioural psychotherapy, has expanded to include drug treatment [ Jannini et al.
Animal and human sexual psychopharmacological studies have demonstrated that serotonin 5-hydroxy-tryptamine, 5-HT and 5-HT receptors are involved in ejaculation and confirm a role for selective serotonin reuptake inhibitors SSRIs in the treatment of PE [ Olivier et al.
Multiple well controlled evidence-based studies have demonstrated the efficacy and safety of SSRIs in delaying ejaculation, confirming their role as first-line agents for the treatment of lifelong and acquired PE [ Waldinger et al.
More recently, there has been increased attention paid to the psychosocial consequences of PE, its epidemiology, its aetiology and its pathophysiology by clinicians and the pharmaceutical industry [ Giuliano et al. All dapoxetine drug-treatment reports and studies were included in the review. The full text of relevant articles was read and critiqued.
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Adequately powered randomized, controlled trials were considered the strongest form of evidence but all other articles were also considered.
The first contemporary multivariate evidence-based definition of lifelong PE was developed in by a panel of international experts, convened by the International Society for Sexual Medicine ISSM , who agreed that the diagnostic criteria necessary to define PE are time from penetration to ejaculation, inability to delay ejaculation and negative personal consequences from PE.
This definition should form the basis for the official diagnosis of lifelong PE. It is limited to heterosexual men engaging in vaginal intercourse as there are few studies available on PE research in homosexual men or during other forms of sexual expression.
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However, recent data suggest that men with acquired PE have similar intravaginal ejaculation latency times IELTs and report similar levels of ejaculatory control and distress, also suggesting the possibility of a single unifying definition of PE [ Porst et al. Reliable information on the prevalence of lifelong and acquired PE in the general male population is lacking.
A core limitation of the GSSAB survey stems from the fact that the youngest participants were aged 40 years, an age when the incidence of PE might be different from younger men [ Jannini and Lenzi, ].
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However, there is a substantial disparity between the incidence of PE in epidemiological studies which rely upon patient self-reporting of PE or inconsistent and poorly validated definitions of PE [ Giuliano et al.
Local and regional variations should be considered in the context of different cultural, religious and political influences.
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Men with type B PE have always suffered from a very rapid ejaculation or short latency , whereas in type A PE, the rapid ejaculation develops later in life and is often associated with erectile dysfunction ED. In , these types were respectively referred to as lifelong primary and acquired secondary PE [ Godpodinoff, ]. Over the years, other attempts have been made to identify various classifications of PE, including several that have been incorporated into PE definitions e.
In , Waldinger proposed the existence of four PE subtypes, with different pathogenesis [ Waldinger, ; Waldinger and Schweitzer, ]. Support for this new classification is gradually developing [ Serefoglu et al. Historically, attempts to explain the aetiology of PE have included a diverse range of biological and psychological theories. Most of these proposed aetiologies are not evidence based and are speculative at best.
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The determinants of PE are undoubtedly complex and multivariate, with the aetiology of lifelong PE different from that of acquired PE. Our understanding of the neurochemical central control of ejaculation is at best rudimentary although recent imaging and electrophysiological studies have identified increased and decreased neuronal activity in several brain areas during arousal and ejaculation [ Hyun et al.
Ejaculatory latency time is probably a genetically determined biological variable which differs between populations and cultures, ranging from extremely rapid through average to slow ejaculation.
The view that some men have a genetic predisposition to lifelong PE is supported by animal studies showing a subgroup of persistent rapidly ejaculating Wistar rats [ Pattij et al.
Acquired PE is commonly due to sexual performance anxiety [ Hartmann et al. The acquired form of PE may be cured by medical or psychological treatment of the underlying cause [ Waldinger and Schweitzer, ].
The off-label use of antidepressant SSRIs, including paroxetine, sertraline, fluoxetine, citalopram and fluvoxamine, and the serotonergic tricyclic clomipramine has revolutionized the approach to and treatment of PE. These drugs block axonal reuptake of serotonin from the synapse by 5-HT transporters, resulting in enhanced 5-HT neurotransmission, stimulation of postsynaptic membrane 5-HT2C receptors and ejaculatory delay. However, the lack of an approved drug and the total reliance on off-label treatment represents a substantial unmet treatment need.
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However, there is some preliminary evidence to suggest that treatment of comorbid risk factors in men with acquired PE, for example, ED and performance anxiety, may be associated with sustained improvement in IELT following SSRI withdrawal [ McMahon, ]. Brain positron emission tomography studies have demonstrated significant displaceable binding of radiolabelled dapoxetine in the cerebral cortex and subcortical grey matter [ Livni et al. The recent report that dapoxetine potently blocks cloned Kv4.
Dapoxetine undergoes rapid absorption and elimination resulting in minimal accumulation and has dose-proportional pharmacokinetics, which are unaffected by multiple dosing and do not vary between ethnic groups Figure 2 [ Dresser et al. The pharmacokinetic profile of dapoxetine suggests that it is a good candidate for on-demand treatment of PE.
Plasma concentration profiles of dapoxetine after administration of a single dose or multiple doses of dapoxetine 30 mg a and dapoxetine 60 mg b [ Modi et al.
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The pharmacokinetics of single doses and multiple doses over 6—9 days 30, 60, , or mg of dapoxetine have been evaluated. In a randomized, double-blind, placebo-controlled trial, single doses and multiple doses over 6 days of dapoxetine 60, , , or mg were administered to 77 healthy male volunteers [ Dresser et al. Dapoxetine has a T max of 1. Both plasma concentration and area under the curve AUC are dose dependent up to mg.
Dapoxetine: a new option in the medical management of premature ejaculation
The mean half life of dapoxetine after a single dose was estimated using modelling as 1. The terminal half life of dapoxetine was 15—19 h after a single dose and 20—24 h after multiple doses of 30 and 60 mg respectively.
In a second pharmacokinetic study, single doses and multiple doses of dapoxetine 30 mg, 60 mg were evaluated in a randomized, open-label, two-treatment, two-period, crossover study of 42 healthy male volunteers over 9 days [ Modi et al. Subjects received a single dose of dapoxetine 30 mg or 60 mg on day 1 single-dose phase and on days 4—9 multiple-dose phase. Elimination of dapoxetine was rapid and biphasic, with an initial half life of 1.
The pharmacokinetics of dapoxetine and its metabolites were not affected by repeated daily dosing and steady state plasma concentrations were reached within 4 days, with only modest accumulation of dapoxetine approximately 1.
Pharmacokinetics of single doses of dapoxetine 30 mg, 60 mg and effect of food on pharmacokinetics [ Dresser et al. Food does not have a clinically significant effect on dapoxetine pharmacokinetics.
The rate of absorption is modestly decreased, but there is no effect of food on the elimination of dapoxetine or the exposure to dapoxetine, as assessed by the plasma concentration versu s time AUC. Dapoxetine is extensively metabolized in the liver by multiple isozymes to multiple metabolites, including desmethyldapoxetine, didesmethyldapoxetine and dapoxetine-n-oxide, which are eliminated primarily in the urine [ Dresser et al.
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Although didesmethyldapoxetine is equipotent to the parent dapoxetine, its substantially lower plasma concentration, compared with dapoxetine, limits its pharmacological activity and it exerts little clinical effect, except when dapoxetine is coadministered with cytochrome P 3A4 CYP3A4 or CYP2D6 inhibitors.
Dapoxetine appears to inhibit the ejaculatory reflex at a supraspinal level with the lateral paragigantocellular nucleus as a necessary brain structure for this effect [ Clement et al.
Clement and colleagues reported the effects of intravenous dapoxetine on the emission and ejection phases of ejaculation using p-chloroamphetamine PCA -induced ejaculation as an experimental model of ejaculation in anesthetized rats [ Clement et al. Intraseminal vesicle pressure and electromyograms of bulbospongiosus muscles were used as physiological markers of the emission and ejection phases respectively.
At the three doses of dapoxetine tested, the latency of PMRD following stimulation of the dorsal nerve of the penis was significantly increased and the amplitude and duration of PMRD decreased from baseline values.
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Acute intravenous paroxetine appeared less effective than dapoxetine. The greatest delay in ejaculatory latency was observed in animals with shorter baseline latencies and oral dapoxetine did not affect the latency in rats with a baseline latency longer than 10 min. Dapoxetine dose-finding data have been derived from two multicentre phase II studies and used to determine the appropriate doses for phase III studies.
The study drug was administered 1—2 h prior to planned sexual intercourse and subjects were required to attempt intercourse at least twice a week.
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The primary outcome measure was the partner-operated stopwatch IELT. Subjects were randomized to receive dapoxetine 20 mg, dapoxetine 40 mg or placebo for 4 weeks with no washout period between treatment arms.
Subjects were randomized to receive dapoxetine 60 mg, dapoxetine mg or placebo for 2 weeks, separated by a 3-day washout period. The intention-to-treat analysis of both studies demonstrated that all four doses of dapoxetine were effective, superior to placebo and increased IELT 2. The magnitude of effect of dapoxetine 20 mg on IELT was small.
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The most commonly reported adverse events AEs were nausea, diarrhoea, headache, dizziness. The incidence of most AEs appeared to be dose dependent. The most common AE was nausea and occurred in 0. Overall, dapoxetine 60 mg was better tolerated than dapoxetine mg. Based on these results, doses of 30 mg and 60 mg were chosen for further investigation in phase III efficacy and safety studies. The five randomized, placebo-controlled, phase III clinical trials comprised two identically designed studies conducted in the USA [ Pryor et al.
The treatment period ranged from 9 to 24 weeks.
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Overall, men with a mean age of This is the largest efficacy and safety database for any agent intended to treat PE. Baseline average IELT was 0. Subjects reported having had PE for an average of Demographic and baseline characteristics were similar across studies, allowing analysis of pooled phase III data.
Outcome measures included stopwatch IELT, the Premature Ejaculation Profile PEP , a validated self-administered four-item tool that includes measures of perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, ejaculation-related interpersonal difficulty [ Patrick et al.
An analysis of pooled phase III data confirms that dapoxetine 30 and 60 mg increased IELT and improved patient-reported outcomes PROs of control, ejaculation-related distress, interpersonal distress and sexual satisfaction compared with placebo. Increases in mean average IELT Table 2 were significantly greater with both doses of dapoxetine versus placebo beginning with the first dose of study medication dapoxetine 30 mg, 2.
By week 12, mean average IELT had increased to 3. Geometric mean average IELT increased from approximately 0. Furthermore, as subjects have a broad range of baseline IELT values 0— s , reporting mean raw trial-end IELT may be misleading by incorrectly suggesting all subjects respond to that extent.
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The trial-end fold increase in geometric mean IELT compared with baseline is more representative of true treatment outcome and must be regarded as the contemporary universal standard for reporting IELT. Geometric mean IELT fold increases of 2. Fold increases were greater among men with very short baseline IELT values, suggesting that dapoxetine may be a useful treatment option for men with severe forms of PE, including anteportal ejaculation.