Priligy (30 mg or 60 mg dapoxetine)
Priligy contains dapoxetine, a selective serotonin re-uptake inhibitor (SSRI), and is authorised for the treatment of premature ejaculation. Priligy should be taken 1 to 3 hours before sexual activity, and the maximum daily dose is one tablet.
Clinical studies have shown that dapoxetine increases the Intravaginal Ejaculation Latency Time (IELT) by an average of 3 to 4 minutes, corresponding to a 2.5-3 fold increase. It is estimated that the increase must be fourfold or more to be clinically relevant. In comparison, placebo showed a 1.6-fold increase in IELT. Dapoxetine also increased the patient-assessed treatment outcome. Randomised, controlled long-term studies determining both IELT and patient-assessed satisfaction have not been conducted. Patients treated with dapoxetine reported a greater frequency of adverse events compared with placebo, and dapoxetine should not be used in combination with alcohol and other recreational drugs, because they increase the risk of neurocognitive and cardiogenic adverse events.
Its IRF’s overall assessment that Priligy should only be used when other treatment options, including cognitive therapy, behavioural methods, off-label use of local analgesics and other SSRIs, have been exhausted. Dapoxetine's effect in relation to placebo is modest, adverse events are frequent and the treatment is very expensive. Moreover, one small study has shown a better effect with paroxetine compared with dapoxetine, and consequently additional comparative clinical studies are called for.
Priligy was marketed on 26 May, and single reimbursement may be applied for at present.