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. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. Literature search methodology All dapoxetine drug-treatment reports and studies were included in the review. ALZA will be responsible for development, manufacturing and commercialisation of dapoxetine for urological indications, including premature ejaculation. Furthermore, one of these studies also found significant differences between dapoxetine both 30 mg and 60 mg and placebo at all time points between baseline and end-of-study.This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon . This paper reviews the current evidence for use of dapoxetine in the treatment of PE in adult men. There is substantial evidence that dapoxetine 30 mg or 60 .  · Although dapoxetine is the only oral pharmacologic agent approved for the treatment of premature ejaculation (PE) and is very effective, the discontinuation rate is .