Premature ejaculation (PE) is a distressing male sexual dysfunction that can be present from the first sexual encounter or can develop later in life. Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. A combination of physiological and psychological factors are believed to impact on ejaculatory latency, and research suggests that serotonin plays a central role. The negative consequences of PE are significant: they cause sexual dissatisfaction, personal distress, interpersonal difficulty, low self-esteem, and they may affect partner satisfaction.
Dapoxetine is the first oral medication approved for "on-demand" treatment of PE. Dapoxetine is a unique, short-acting, selective serotonin reuptake inhibitor designed to be taken only when needed - one to three hours before sexual intercourse is anticipated - rather than every day. Dapoxetine was originally developed by Janssen, and is specifically indicated for the on-demand treatment of PE. Over 15,000 men have received Dapoxetine in pre-marketing and post-marketing clinical studies, where it was well-tolerated and demonstrated to have a favorable safety profile. This is the largest and most comprehensive clinical trial program to date for a drug therapy to treat PE. Randomized, double-blind, controlled studies of dapoxetine have demonstrated statistically significant and clinically meaningful efficacy across a variety of clinical outcome measures including: stopwatch-measured intravaginal ejaculatory latency time (IELT, see Figure), and improvement in a composite endpoint of patient reported outcomes involving: perceived control over ejaculation; satisfaction with sexual intercourse; personal distress related to ejaculation and interpersonal difficulty related to ejaculation.