Patient-reported outcome-defined level of clinical benefit Three of the RCTs in Table 3 also reported a predefined composite clinical outcome as a measure of clinical benefit following dapoxetine treatment. All three integrated analyses found significant improvements in satisfaction with sexual intercourse at study endpoint. While FDB Multilex use reputable sources of information, such as published data of pharmaceutical manufacturers, it does not validate or verify the information received from third parties. This is an open access article. Abstract Introduction Premature ejaculation PE is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological factors. It therefore cannot be relied upon as complete.Dapoxetine is absorbed and distributed rapidly in the body. Greater than 99% of dapoxetine is bound to the plasma protein. The mean steady-state volume is L. Its initial half-life is hours (30 mg dose) and hours (60 mg dose), and its terminal half life is hours (30 mg dose) and hours (60 mg dose). Metabolism. Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature. The most common treatment-related adverse effects included nausea (% for 30 mg, % for 60 mg), dizziness (% for 30 mg, % for 60 mg), and headache (% for 30 mg, % for 60 mg), and evaluation of validated rated scales demonstrated no SSRI class-related effects with dapoxetine use.