An analysis of two trials,1 in which 2614 men (aged 18–77 years) were randomised to dapoxetine (30 mg or 60 mg) or placebo (all taken 1–3 hours before intercourse), found that dapoxetine increased intravaginal ejaculatory latency time significantly more than placebo.
"Stereoselective synthesis of (S)-dapoxetine starting from trans-cinnamyl alcohol". "Medical Non-Endocrine-Targeted Therapies: Ejaculatory Dysfunction and Immunotherapy". Priligy (drug name Dapoxetine), is classed as a fast-acting selective serotonin reuptake inhibitor (SSRI) and works by increasing the level of serotonin, a natural chemical in the body. This increased serotonin causes a delayed reaction in the area of the brain that triggers ejaculation. This means that reaching orgasm after taking Priligy takes longer. At baseline, men were required to have an intravaginal ejaculatory latency time of 2 minutes or less at least 75% of the time.
Like all medicines, Priligy does have some potential side effects. The most common are nausea, headache and dizziness (approx 1 in 10 users). These can feel more intense the first few times you try Priligy and settle down as you get used to the treatment. Make sure you’re well hydrated when you use Priligy as the medicine does slightly dehydrate you, this can also stave off headaches and dizziness You shouldn’t drink alcohol or use recreational drugs with Priligy either, it can affect how well the treatment works and can make side effect symptoms more intense If you do get a headache, it is safe to use a painkiller such as paracetamol with Priligy Priligy can be taken with or without food but I would recommend taking it with a light meal or at least not on an empty stomach. This will reduce the possibility of nausea with Priligy You can also play around with how far in advance you take the Priligy, as it can be taken from 1 to 3 hours before sex and that’s quite a big window. After 12 weeks, 29% of men taking the 30 mg dose and 34% taking the 60 mg dose had a latency time of 3 minutes or more. This was compared to only 14% of men taking placebo. Men taking dapoxetine perceived that they had better control of ejaculation and were more satisfied with their sexual performance than those taking placebo. In another trial, dapoxetine (60 mg) was compared to paroxetine (20 mg), another SSRI, in 340 men (aged 22–48 years) with premature ejaculation. Treatments were taken each day divided into two doses. After 12 weeks, intravaginal ejaculatory latency times had increased from 38 to 179 seconds for dapoxetine, from 31 seconds to 370 seconds for paroxetine, and from 34 to 55 seconds for placebo. More men reported sexual satisfaction with dapoxetine and paroxetine than with placebo (66% vs 78% vs 16%). A similar trend in sexual satisfaction was seen with partners who were interviewed independently of their husband. Eleven men dropped out because of lack of efficacy – 3/104 with dapoxetine, 2/105 with paroxetine and 6/100 with placebo.
Some customers have found that taking Priligy on a fuller stomach 2-3 hours before sex has significantly helped them avoid nausea and given them a better result, but remember everyone is different A chemical in grapefruit juice can increase the amount of dapoxetine in your bloodstream and this increases the risk of side-effects. If you do drink grapefruit juice, do not take a dapoxetine tablet for at least 24 hours afterwards Stay hydrated, avoid alcohol and with a few test runs you’ll soon figure out the best way to get Priligy working for you. Have you seen our Stud 100 delay spray? As always, we are very happy to answer questions or provide further confidential advice. or call our experienced and healthcare trained team on 01295 262925. The timing of dosing in relation to sexual intercourse was not described in this trial.6 During the trials, nausea (11%), headache (5.6%), diarrhoea (3.5%), somnolence (3.1%) and dizziness (5.8%) were more commonly reported with dapoxetine 30 mg than with placebo. These events were dose-related – all of them were more frequent with the 60 mg dapoxetine dose. Nausea and dizziness were the most common reasons for discontinuation with dapoxetine 30 mg. Because of the increased risk of adverse events, patients should be warned to take no more than one tablet in a 24-hour period. Sexual adverse effects including erectile dysfunction, abnormal ejaculation and decreased libido were more common with dapoxetine than placebo. These occurred in 2.9% of patients taking dapoxetine 30 mg and 3.8% taking dapoxetine 60 mg versus 1.5% of patients taking placebo.1 Postural hypotension occurred in some patients and caution is urged with concomitant use of vasodilators such as alpha blockers, nitrates and phosphodiesterase 5 inhibitors. Syncope has been reported with dapoxetine and appeared to be dose-related (0.05% with placebo, 0.06% with 30 mg and 0.23% with 60 mg dose). Possible prodromal symptoms such as nausea, dizziness and light-headedness were also more common with dapoxetine than with placebo. Patients should be warned about this risk and advised to maintain adequate hydration and avoid alcohol.
"Cardiovascular safety profile of dapoxetine during the premarketing evaluation". "Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports". "Selective serotonin reuptake inhibitor discontinuation syndrome: a review". "Emerging treatments for premature ejaculation: focus on dapoxetine". "Dapoxetine: a novel treatment for premature ejaculation". Dapoxetine is metabolised by enzymes in the liver and kidneys, in particular cytochrome P450 (CYP) 2D6 and 3A4. It also moderately inhibits CYP 2D6 and weakly induces CYP 3A4 so numerous interactions are expected. Poor CYP 2D6 metabolisers may be at increased risk of adverse events. Concomitant treatment with potent CYP 3A4 inhibitors such as ketoconazole and ritonavir is contraindicated. Dapoxetine is also contraindicated with antidepressants including monoamine oxidase inhibitors, serotonin reuptake inhibitors, tricyclics and other drugs with serotonergic effects (tramadol, St John’s wort and lithium). Dapoxetine should not be taken in combination with recreational drugs such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) because of the potential risk of serious adverse events including arrhythmia, hyperthermia and serotonin syndrome. Concomitant sedatives can increase the risk of somnolence and dizziness.
ISSUE 6 DECEMBER New drugDapoxetine for premature ejaculation Approved indication: premature ejaculation Priligy (A Menarini) 30 mg tablets Australian Medicines Handbook section 13.3.2 Delayed ejaculation is an adverse effect of selective serotonin reuptake inhibitors (SSRIs) in men. Dapoxetine, a short-acting SSRI, is the first drug to be marketed for premature ejaculation. After oral administration, peak plasma concentrations of dapoxetine are reached after an hour. Elimination is relatively rapid and the terminal half-life is approximately 19 hours. There have been several randomised controlled trials of dapoxetine for premature ejaculation.1-6 The primary outcome for most of the trials was ‘intravaginal ejaculatory latency time’ measured by the partner using a stopwatch. Dapoxetine is contraindicated in patients with heart problems such as heart failure, conduction abnormalities or significant ischaemic or valvular disease. It is also contraindicated in moderate and severe hepatic impairment. Dapoxetine is not recommended in patients with severe renal impairment or with psychiatric disorders. Although dapoxetine prolongs intravaginal latency time before ejaculation, improvements seem modest and a placebo effect was apparent in most of the studies. In an analysis of two trials, mean latency time increased from an average of 0.9 minutes at baseline to 1.75 minutes with placebo and 2.78 minutes with dapoxetine (30 mg taken on-demand).1 In a comparative trial, paroxetine was more effective than dapoxetine, although it was unclear when treatment was taken in relation to sexual intercourse. This may have affected efficacy.6 The benefits and adverse effects of dapoxetine treatment should be reviewed after four weeks (or six doses). Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind randomised trials. Buvat J, Tesfaye F, Rothman M, Rivas DA, Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med 2010;7:256-68.
"Physiology of ejaculation: emphasis on serotonergic control". "Supraspinal site of action for the inhibition of ejaculatory reflex by dapoxetine". "Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials". ^ "Dapoxetine: a guide to its use in premature ejaculation". "Pharmacokinetics of single and multiple escalating doses of dapoxetine in healthy volunteers". Safarinejad MR. Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Kaufman JM, Rosen RC, Mudumbi RV, Tesfaye F, Hashmonay R, Rivas D. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial. Comparison of dapoxetine versus paroxetine in patients with premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value.
